A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: rituximab [MabThera/Rituxan]; Drug: methotrexate; Drug: methylprednisolone

• Registration Number: NCT02006706
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This study will evaluate the efficacy and safety of MabThera/Rituxan plus methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to at least 1 DMARD treatment. All patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and methotrexate (10-25mg po) weekly. The anticipated time on study treatment is 3-12 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-10
• Primary Completion: 2007-11-23
• Study Completion: 2007-11-23
• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-10
• Results First Submitted: 2014-10-31
• Results First Submitted QC: 2014-10-31
• Results First Posted: 2014-11-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-17
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• adult patients, 18-80 years of age;
• rheumatoid arthritis after inadequate response to >=1 DMARD treatment;
• active disease;
• DMARDs other than methotrexate withdrawn for at least 4 weeks prior to start of study treatment.

Exclusion Criteria

• autoimmune disease other than rheumatoid arthritis;
• bone/joint surgery within 8 weeks prior to screening, or joint surgery planned within 24 weeks of MabThera infusion;
• concurrent treatment with any DMARD or antiTNF-alfa;
• intra-articular or parenteral corticosteroids within 4 weeks prior to screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MabThera/Rituxan	rituximab [MabThera/Rituxan]	-
MabThera/Rituxan	methotrexate	-
MabThera/Rituxan	methylprednisolone	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24	Baseline, Week 24	DAS28 was calculated from the number of swollen joints and painful joints 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 using visual analog scale \[VAS\]) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (\>)3.2 to 5.1 = moderate to high disease activity.

Secondary Outcome Measures

Name	Time	Method
Health Assessment Questionnaire-Disability Index (HAQ-DI)	Baseline, Week 24	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.