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

NCT ID: NCT02006706

Last Updated: 2017-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-10
• Study Completion Date: 2007-11-23

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MabThera/Rituxan

Group Type: EXPERIMENTAL

rituximab [MabThera/Rituxan]

Intervention Type: DRUG

1000 mg iv Days 1 and 15

methotrexate

Intervention Type: DRUG

10 - 25 mg/week

methylprednisolone

Intervention Type: DRUG

iv administration on Day 1 and 15 prior to MabThera/Rituxan infusion

Interventions

rituximab [MabThera/Rituxan]

1000 mg iv Days 1 and 15

Intervention Type: DRUG

methotrexate

10 - 25 mg/week

Intervention Type: DRUG

methylprednisolone

iv administration on Day 1 and 15 prior to MabThera/Rituxan infusion

Intervention Type: DRUG

Eligibility Criteria

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• DMARDs other than methotrexate withdrawn for at least 4 weeks prior to start of study treatment.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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Belgrade, , Serbia

Niška Banja, , Serbia

Nova Sad, , Serbia

Countries

Serbia

Other Identifiers

ML20388

Identifier Type: -

Identifier Source: org_study_id