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A Study of the Safety and Efficacy of Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Methotrexate (RUMBA)

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Genentech

Status and phase

Completed
Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Drug: folate
Drug: methylprednisolone
Drug: Placebo
Drug: Rituximab
Drug: methotrexate

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

This was a Phase II, randomized, double-blind, multicenter study designed to evaluate the safety and efficacy of rituximab, administered at two different regimens for 2 years, in patients with moderate to severe active rheumatoid arthritis (RA) receiving stable doses of methotrexate (MTX).

Enrollment

42 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of RA for at least 6 months.
  • Inadequate response to MTX
  • Use of folate
  • If female and of childbearing potential, have a negative serum pregnancy test within 8 weeks prior to first rituximab infusion

Exclusion criteria

  • Diagnosis of juvenile idiopathic arthritis (also known as juvenile rheumatoid arthritis) and/or RA before age 16
  • Any surgical procedure, including bone/joint surgery or planned surgery within 8 weeks prior to screening or within 16 weeks of Week 1 (Day 1) visit
  • Inflammatory arthritis other than RA (e.g., inflammatory bowel disease, systemic lupus erythematosus (SLE), or psoriatic arthritis)
  • Functional Class IV as defined by the American College of Rheumatology (ACR) classification of functional status in RA
  • Use of disease-modifying anti-rheumatic drugs (DMARDs) other than MTX within 4 weeks prior to randomization (8 weeks prior for infliximab, adalimumab, or leflunomide)
  • Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
  • Previous treatment with Tysabri<TM> (natalizumab)
  • Previous treatment with rituximab
  • Previous treatment with any cell-depleting therapies, including investigational agents
  • Treatment with IV &-globulin or Prosorba(R) Column within the previous 6 months
  • Use of intra-articular or parenteral corticosteroids within 4 weeks prior to screening visit
  • Receipt of a vaccine within 4 weeks prior to Day 1 infusion
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  • Primary or secondary immunodeficiency (history of or active)
  • Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, renal, hepatic, endocrine, gastrointestinal, or pulmonary disease, including any pulmonary or other condition that would preclude subject participation over the ensuing 2 years
  • Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds)
  • History of recurrent significant infection or any significant episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
  • History of significant cytopenias or other bone marrow disorders
  • History of cancer, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinoma of the skin that have been excised and cured)
  • Pregnant or nursing (breast feeding) women
  • Lack of peripheral venous access
  • Chronic daily use of narcotic analgesics
  • History of alcohol, drug, or chemical abuse within 6 months prior to screening

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

42 participants in 2 patient groups

Arm A: 500 mg Rituximab
Experimental group
Description:
Rituximab: 1000 mg intravenous (IV) on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15-25 mg/wk oral or parenteral (10-14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
Treatment:
Drug: methylprednisolone
Drug: methotrexate
Drug: folate
Drug: Rituximab
Arm B: 1000 mg Rituximab
Experimental group
Description:
Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12.) For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15-25 mg/wk oral or parenteral (10-14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
Treatment:
Drug: Placebo
Drug: methylprednisolone
Drug: methotrexate
Drug: folate
Drug: Rituximab

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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