A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate

Rheumatoid Arthritis Clinical Trial

Official title:

An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00934648
• Other study ID #: ML20546
• Status: Completed
• Phase: Phase 4
• First received: July 6, 2009
• Last updated: June 9, 2014
• Start date: October 2007
• Est. completion date: November 2010

Study information

• Verified date: June 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Morocco: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who have had an inadequate response or were intolerant to treatment with methotrexate. Eligible patients will receive MabThera (1000mg by intravenous infusion) on days 1 and 15, and background methotrexate (oral or subcutaneous dose of 10-25mg weekly). After the initial study period of 24 weeks, eligible patients may receive up to 3 re-treatments with MabThera. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• receiving out-patient treatment;

• experienced an inadequate response to previous or current treatment with methotrexate.

Exclusion Criteria:

• rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA;

• history of, or current, inflammatory joint disease other than RA;

• previous treatment with any cell-depleting therapies.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• rituximab [MabThera/Rituxan]
1000mg iv on days 1 and 15
• methotrexate
10-25mg weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Morocco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With an Adverse Event (AE)		Week 104	No
Secondary	Disease Activity Score Based on 28-Joint Count (DAS28)	DAS28 was calculated from the number of swollen joints and tender joints using the 28 joint count; the erythrocyte sedimentation rate (ESR) measured in millimeters per hour [mm/hr]); and the Patient's Global Assessment of disease activity (participant-rated visual analog assessment [VAS]) with transformed scores with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Overall, a DAS28 score of less than or equal to (=) 3.2 equals (=) low disease activity, and a DAS28 score of greater than (>) 3.2 to 5.1 = moderate to high disease activity.	Day 1 and Week 24	No
Secondary	Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category	DAS28-based EULAR response criteria were used to measure individual response as no response, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline greater than (>)1.2 with DAS28 less than or equal to (=)3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =5.1 or change from baseline >0.6 to =1.2 with DAS28 =5.1; non-responders: change from baseline =0.6 or change from baseline >0.6 and =1.2 with DAS28 >5.1.	Screening, Day 1, and Weeks 24 and 104	No
Secondary	Percentage of Participants With Changes in Bone Density	Change in bone density in participants untreated with bisphosphonates was classified as percentage of participants with osteoporosis, osteopenia, or normal. In some participants, no determinations were available.	Screening, Weeks 48 and 104	No