A Study of Efficacy of Rituximab [Mabthera/Rituxan] in Patients With Rheumatoid Arthritis Using Magnetic Resonance Imaging of the Hand (RESONAR)

Rheumatoid Arthritis Clinical Trial

Official title:

Efficacy of MabThera in Patients With Rheumatoid Arthritis, by Measurement of Disease Parameters Through Magnetic Resonance of the Hand (RESONAR Study)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01117129
• Other study ID #: ML21826
• Secondary ID: 2008-002381-55
• Status: Terminated
• Phase: Phase 4
• First received: May 4, 2010
• Last updated: March 27, 2014
• Start date: April 2010
• Est. completion date: June 2010

Study information

• Verified date: March 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

This randomized, double-blind, placebo controlled, parallel group study will assess the efficacy and safety of rituximab [MabThera/Rituxan] in patients with severe active rheumatoid arthritis refractory to at least one anti-TNF treatment, using magnetic resonance imaging (MRI) of the hand for efficacy measurement. Patients will be randomized to receive 2 intravenous infusions 14 days apart of either 1000mg MabThera (group A) or placebo (group B). All patients will receive methotrexate 10-25mg weekly. Patients in group A demonstrating clinical response at week 24 may receive further cycles of MabThera, patients in group B without clinical response will also be treated with active MabThera. Anticipated time on study treatment is up to 2 years. Target sample size is <50 patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• adult patients, 18-75 years of age

• active rheumatoid arthritis (DAS28-CRP>3.2)

• refractory to one or more anti-TNF

• on stable treatment for RA for >/=4 weeks

• evidence of erosive disease and/or synovitis in wrist and/or knuckles

Exclusion Criteria:

• active systemic or local infection

• previous or current history of any demyelinization process in central nervous system, pancytopenia or aplasic anaemia

• signs of immunodeficiency, HIV infection or tuberculosis

• contraindications to MRI, such as metal devices, claustrophobia, moderate or severe renal insufficiency, or allergy to contrast agent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• rituximab [MabThera/Rituxan]
1000 mg by i.v. infusion on day 1 and 15
• placebo
i.v. infusion on day 1 and 15
• methotrexate
10-25 mg weekly
• rituximab [Mabthera/Rituxan]
1000 mg by i.v. infusion on day 1 and 15, 2nd and further cycles in patients with (group A) or without (group B) clinical response in cycle 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone erosion score on magnetic resonance imaging (MRI) using the rheumatoid arthritis magnetic resonance imaging scoring system (RAMRIS)		6 months	No
Secondary	Synovitis score on MRI using RAMRIS		months 6, 12 and 24	No
Secondary	Bone edema score on MRI using RAMRIS		months 6, 12 and 24	No
Secondary	Bone erosion score on MRI using RAMRIS		months 12 and 24	No
Secondary	Disease activity according to DAS28-CRP		months 12 and 24	No
Secondary	Tender or swollen joint count (ACR criteria)		months 12 and 24	No
Secondary	Health assessment questionnaire (HAQ)		months 12 and 24	No