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

Sponsor
Hoffmann-La Roche
Study ID
NCT02006706
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab [MabThera/Rituxan] — DRUG
    1000 mg iv Days 1 and 15
  • methotrexate — DRUG
    10 - 25 mg/week
  • methylprednisolone — DRUG
    iv administration on Day 1 and 15 prior to MabThera/Rituxan infusion

Study Details

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.

Key Dates

Start date
Aug 10, 2006
Status verified
Jul 2017
Primary completion
Nov 23, 2007
Completion
Nov 23, 2007

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MabThera/Rituxan

Primary Outcome Measure

Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24 [ Time Frame: Baseline, Week 24 ]

Related Studies