Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— SPEED  

Official title:

Multicenter, Open Label Study to Evaluate the Predictability of Early Response to Certolizumab Pegol (in Combination With Methotrexate) as Confirmed at Week 52 in Subjects With Moderate-severe Rheumatoid Arthritis (RA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01443364
• Other study ID #: RA0069
• Secondary ID: 2011-000385-35
• Status: Completed
• Phase: Phase 4
• First received: September 27, 2011
• Last updated: June 10, 2015
• Start date: December 2011
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The study aims to evaluate the predictability of early response to Certolizumab pegol in combination with Methotrexate at one year in patients with moderate to severe rheumatoid arthritis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of adult-onset Rheumatoid Arthritis (RA) for a duration of at least 6 months but not longer than 5 years

• positive Rheumatoid Factor (RF) and/or positive anti Cyclic Citrullinated Peptide (anti-CCP)

• active RA disease

• subjects must have failed at least one traditional Disease Modifying Anti-Rheumatic Drug (DMARD).

• subject is naïve to RA related biologics

Exclusion Criteria:

• a diagnosis of any other inflammatory arthritis

• history of infected joint prosthesis, or other significant infection

• known Tuberculosis (TB) disease or high risk of acquiring TB infection

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• Certolizumab pegol
Prefilled syringes containing an injectable volume of 1ml of liquid Certolizumab Pegol (CZP) for single use at a dosage strength of 200 mg/ml. Injections will be given subcutaneously. CZP 400 mg at Week 0, 2 and 4, then continued as maintenance dose of 200 mg every 2 weeks until Week 50.

Locations

Country	Name	City	State
Italy	11	Bari
Italy	08	Catania
Italy	10	Ferrara
Italy	12	Firenze
Italy	01	Jesi
Italy	05	Milano
Italy	13	Milano
Italy	18	Milano
Italy	07	Modena
Italy	23	Monserrato
Italy	20	Napoli
Italy	16	Padova
Italy	06	Roma
Italy	21	Roma
Italy	22	Siena
Italy	09	Torino
Italy	04	Udine
Italy	02	Verona

Sponsors (1)

Lead Sponsor	Collaborator
UCB Italy s.p.a.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of subjects with clinical response at Week 12 who also had clinical response at Week 52	Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28[Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system	From Baseline to Week 12 and Week 52	No
Primary	The percentage of subjects with clinical response at Week 8 who also had clinical response at Week 52	Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28[Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system	From Baseline to Week 8 and Week 52	No
Primary	The percentage of subjects with clinical response at Week 6 who also had clinical response at Week 52	Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28[Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system	From Baseline to Week 6 and Week 52	No
Primary	The percentage of subjects with clinical response at Week 4 who also had clinical response at Week 52	Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28[Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system	From Baseline to Week 4 and Week 52	No
Primary	The percentage of subjects with clinical response at Week 2 who also had clinical response at Week 52	Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28[Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system	From Baseline to Week 2 and Week 52	No
Primary	The percentage of subjects with clinical response at Week 1 who also had clinical response at Week 52	Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28[Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system	From Baseline to Week 1 and Week 52	No
Secondary	Change from Baseline in the synovial fluid and proliferation at Week 52	The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 52	No
Secondary	Change from Baseline in the synovial fluid and proliferation at Week 36	The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 36	No
Secondary	Change from Baseline in the synovial fluid and proliferation at Week 24	The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 24	No
Secondary	Change from Baseline in the synovial fluid and proliferation at Week 12	The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 12	No
Secondary	Change from Baseline in the synovial fluid and proliferation at Week 8	The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 8	No
Secondary	Change from Baseline in the synovial fluid and proliferation at Week 6	The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 6	No
Secondary	Change from Baseline in the synovial fluid and proliferation at Week 4	The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 4	No
Secondary	Change from Baseline in the synovial fluid and proliferation at Week 2	The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 2	No
Secondary	Change from Baseline in the synovial fluid and proliferation at Week 1	The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 1	No
Secondary	Change from Baseline in the Doppler signal and blood flow at Week 52	The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 52	No
Secondary	Change from Baseline in the Doppler signal and blood flow at Week 36	The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 36	No
Secondary	Change from Baseline in the Doppler signal and blood flow at Week 24	The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 24	No
Secondary	Change from Baseline in the Doppler signal and blood flow at Week 12	The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 12	No
Secondary	Change from Baseline in the Doppler signal and blood flow at Week 8	The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 8	No
Secondary	Change from Baseline in the Doppler signal and blood flow at Week 6	The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 6	No
Secondary	Change from Baseline in the Doppler signal and blood flow at Week 4	The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 4	No
Secondary	Change from Baseline in the Doppler signal and blood flow at Week 2	The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 2	No
Secondary	Change from Baseline in the Doppler signal and blood flow at Week 1	The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 1	No
Secondary	Change from Baseline in the Cartilage damage at Week 52	The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 52	No
Secondary	Change from Baseline in the Cartilage damage at Week 36	The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 36	No
Secondary	Change from Baseline in the Cartilage damage at Week 24	The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 24	No
Secondary	Change from Baseline in the Cartilage damage at Week 12	The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 12	No
Secondary	Change from Baseline in the Cartilage damage at Week 8	The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 8	No
Secondary	Change from Baseline in the Cartilage damage at Week 6	The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 6	No
Secondary	Change from Baseline in the Cartilage damage at Week 4	The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 4	No
Secondary	Change from Baseline in the Cartilage damage at Week 2	The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 2	No
Secondary	Change from Baseline in the Cartilage damage at Week 1	The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 1	No
Secondary	Change from Baseline in the bone erosion at Week 52	The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 52	No
Secondary	Change from Baseline in the bone erosion at Week 36	The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 36	No
Secondary	Change from Baseline in the bone erosion at Week 24	The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 24	No
Secondary	Change from Baseline in the bone erosion at Week 12	The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 12	No
Secondary	Change from Baseline in the bone erosion at Week 8	The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 8	No
Secondary	Change from Baseline in the bone erosion at Week 6	The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 6	No
Secondary	Change from Baseline in the bone erosion at Week 4	The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 4	No
Secondary	Change from Baseline in the bone erosion at Week 2	The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 2	No
Secondary	Change from Baseline in the bone erosion at Week 1	The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 1	No
Secondary	Change from Baseline in the sum of the synovial fluid volume and hypertrophy score at Week 52	The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 52	No
Secondary	Change from Baseline in the sum of the synovial fluid volume and hypertrophy score at Week 36	The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 36	No
Secondary	Change from Baseline in the sum of the synovial fluid volume and hypertrophy score at Week 24	The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 24	No
Secondary	Change from Baseline in the sum of the synovial fluid volume and hypertrophy score at Week 12	The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 12	No
Secondary	Change from Baseline in the sum of the synovial fluid volume and hypertrophy score at Week 8	The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 8	No
Secondary	Change from Baseline in the sum of the synovial fluid volume and hypertrophy score at Week 6	The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 6	No
Secondary	Change from Baseline in the sum of the synovial fluid volume and hypertrophy score at Week 4	The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 4	No
Secondary	Change from Baseline in the sum of the synovial fluid volume and hypertrophy score at Week 2	The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 2	No
Secondary	Change from Baseline in the sum of the synovial fluid volume and hypertrophy score at Week 1	The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.	From Baseline to Week 1	No
Secondary	Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 52	The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 52	No
Secondary	Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 36	The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 36	No
Secondary	Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 24	The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 24	No
Secondary	Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 12	The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 12	No
Secondary	Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 8	The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 8	No
Secondary	Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 6	The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 6	No
Secondary	Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 4	The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 4	No
Secondary	Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 2	The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 2	No
Secondary	Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 1	The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.	From Baseline to Week 1	No
Secondary	Synovial fluid and proliferation at Week 52	The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	Week 52	No
Secondary	Synovial fluid and proliferation at Week 36	The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	Week 36	No
Secondary	Synovial fluid and proliferation at Week 24	The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	Week 24	No
Secondary	Synovial fluid and proliferation at Week 12	The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	Week 12	No
Secondary	Synovial fluid and proliferation at Week 8	The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	Week 8	No
Secondary	Synovial fluid and proliferation at Week 6	The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	Week 6	No
Secondary	Synovial fluid and proliferation at Week 4	The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	Week 4	No
Secondary	Synovial fluid and proliferation at Week 2	The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	Week 2	No
Secondary	Synovial fluid and proliferation at Week 1	The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	Week 1	No
Secondary	Synovial fluid and proliferation at Week 0	The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	Week 0 (Baseline)	No
Secondary	Doppler signal and blood flow at Week 52	The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	Week 52	No
Secondary	Doppler signal and blood flow at Week 36	The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	Week 36	No
Secondary	Doppler signal and blood flow at Week 24	The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	Week 24	No
Secondary	Doppler signal and blood flow at Week 12	The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	Week 12	No
Secondary	Doppler signal and blood flow at Week 8	The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	Week 8	No
Secondary	Doppler signal and blood flow at Week 6	The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	Week 6	No
Secondary	Doppler signal and blood flow at Week 4	The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	Week 4	No
Secondary	Doppler signal and blood flow at Week 2	The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	Week 2	No
Secondary	Doppler signal and blood flow at Week 1	The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	Week 1	No
Secondary	Doppler signal and blood flow at Week 0	The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.	Week 0 (Baseline)	No
Secondary	Cartilage damage at Week 52	The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	Week 52	No
Secondary	Cartilage damage at Week 36	The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	Week 36	No
Secondary	Cartilage damage at Week 24	The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	Week 24	No
Secondary	Cartilage damage at Week 12	The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	Week 12	No
Secondary	Cartilage damage at Week 8	The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	Week 8	No
Secondary	Cartilage damage at Week 6	The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	Week 6	No
Secondary	Cartilage damage at Week 4	The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	Week 4	No
Secondary	Cartilage damage at Week 2	The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	Week 2	No
Secondary	Cartilage damage at Week 1	The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	Week 1	No
Secondary	Cartilage damage at Week 0	The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	Week 0 (Baseline)	No
Secondary	Bone erosion at Week 52	The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	Week 52	No
Secondary	Bone erosion at Week 36	The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	Week 36	No
Secondary	Bone erosion at Week 24	The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	Week 24	No
Secondary	Bone erosion at Week 12	The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	Week 12	No
Secondary	Bone erosion at Week 8	The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	Week 8	No
Secondary	Bone erosion at Week 6	The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	Week 6	No
Secondary	Bone erosion at Week 4	The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	Week 4	No
Secondary	Bone erosion at Week 2	The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	Week 2	No
Secondary	Bone erosion at Week 1	The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	Week 1	No
Secondary	Bone erosion at Week 0	The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.	Week 0 (Baseline)	No
Secondary	Sum of the synovial fluid volume and hypertrophy score at Week 52	The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.	Week 52	No
Secondary	Sum of the synovial fluid volume and hypertrophy score at Week 36	The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.	Week 36	No
Secondary	Sum of the synovial fluid volume and hypertrophy score at Week 24	The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.	Week 24	No
Secondary	Sum of the synovial fluid volume and hypertrophy score at Week 12	The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.	Week 12	No
Secondary	Sum of the synovial fluid volume and hypertrophy score at Week 8	The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.	Week 8	No
Secondary	Sum of the synovial fluid volume and hypertrophy score at Week 6	The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.	Week 6	No
Secondary	Sum of the synovial fluid volume and hypertrophy score at Week 4	The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.	Week 4	No
Secondary	Sum of the synovial fluid volume and hypertrophy score at Week 2	The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.	Week 2	No
Secondary	Sum of the synovial fluid volume and hypertrophy score at Week 1	The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.	Week 1	No
Secondary	Sum of the synovial fluid volume and hypertrophy score at Week 0	The sum of the synovial fluid volume and hypertrophy score is a score (0-6 on each of 6 joints). A greater score indicates greater disease activity.	Week 0 (Baseline)	No
Secondary	Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 52	The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.	Week 52	No
Secondary	Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 36	The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.	Week 36	No
Secondary	Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 24	The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.	Week 24	No
Secondary	Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 12	The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.	Week 12	No
Secondary	Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 8	The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.	Week 8	No
Secondary	Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 6	The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.	Week 6	No
Secondary	Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 4	The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.	Week 4	No
Secondary	Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 2	The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.	Week 2	No
Secondary	Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 1	The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.	Week 1	No
Secondary	Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 0	The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.	Week 0 (Baseline)	No