Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic Treatment

Rheumatoid Arthritis Clinical Trial

Official title:

A Retrospective Evaluation of the Radiographic Efficacy of Different Conventional Systemic Therapies and Biologics in Patients With Rheumatoid Arthritis in Routine Practice.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929357
• Other study ID #: 0881X1-4617
• Status: Completed
• Phase: N/A
• First received: June 25, 2009
• Last updated: August 4, 2011
• Start date: August 2009
• Est. completion date: June 2010

Study information

• Verified date: August 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

This study involves review and analysis of disease activity in patients with rheumatoid arthritis who where treated with either conventional DMARDs (Disease Modifying Antirheumatic Drugs) or Biologics and have two existing, consecutive radiographs (x-ray images) of hand and feet taken as part of routine treatment monitoring within a time interval of 12 to 36 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Secure diagnosis of rheumatoid arthritis

• Older than 18 years

• Two consecutive plain radiographs of the hands and feet with a time interval of 12 to 36 months are available. The radiographs are recorded 2003 or later and are in accordance with a defined X-ray protocol.

Exclusion Criteria:

• Patients who receive Anakinra, Rituximab or Abatacept

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• DMARDs or Biologics

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Joint Status Assessed by Radiographic (Roentgen) Progression	Radiographic progression assessed using Ratingen score with range of 0 = normal joint; 1 = one or more erosions, <20% of the joint surface are destroyed; 2 = 21% to 40% of the joint surface are destroyed; 3 = 41% to 60% of joint surface are destroyed; 4 = 61% to 80% of the joint surface are destroyed; 5 = >80% of the joint surface are destroyed. Total possible score based on 38 joints was 0 to 190; higher scores indicated greater joint destruction. Annualized change in Ratingen score calculated as (total change in Ratingen score / time period between radiograph 1 and 2 [months])*12 months.	Baseline (Day 0) up to 48 months	No
Secondary	Number of Participants Without Radiographic Progression	An increase of 4 or more points in the Ratingen score was necessary to detect a difference in radiographic progression. Ratingen score range 0 = normal joint to 5 = >80% of the joint surface are destroyed. Total possible score based on 38 joints was 0 to 190; higher scores indicated greater joint destruction. A decrease of 4 (smallest detectable difference) or more points in total Ratingen score was considered a decrease in erosive damage.	Baseline (Day 0) up to 48 months	No
Secondary	Number of Participants Without Erosions	Radiographic assessment of no erosions using Ratingen scoring categorized as score of 0=normal joint.	Baseline (Day 0) up to 48 months	No
Secondary	Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28)	DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 =3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.	Baseline (Day 0) up to 48 months	No
Secondary	Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Erythrocyte Sedimentation Rate measured as millimeters per hour (mm/h).	Baseline (Day 0) up to 48 months	No
Secondary	Change From Baseline in C-reactive Protein (CRP)	C-reactive protein measured as milligrams per liter (mg/l)	Baseline (Day 0) up to 48 months	No
Secondary	Number of Participants With Change From Baseline in Rheumatoid Factor (RF)	Rheumatoid Factor measured as a titer and categorized as negative (<1:16 ratio) or positive. A ratio >1:16 indicates a higher level of RF.	Baseline (Day 0) up to 48 months	No
Secondary	Number of Participants With Laboratory Result for Cyclic Citrullinated Peptide-autoantibody-test (CCP)	Cyclic citrullinated peptide-autoantibody-test measured as Enzyme-linked immunosorbent assay (ELISA units or EU) and categorized as negative (<20 EU) or positive (=20 up to >60 EU).	Baseline (Day 0) up to 48 months	No