Safety and Efficacy Study of Re-treatment With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Respond Poorly to Anti-TNFα Therapies

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00468377
First received: April 30, 2007
Last updated: November 23, 2011
Last verified: November 2011
  Purpose

The purpose of this study is to determine whether repeat treatments with rituximab are safe and effective in patients with rheumatoid arthritis who no longer respond to anti-TNF therapies.


Condition Intervention Phase
Arthritis, Rheumatoid
Drug: Rituximab
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNFα Therapies

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • The primary endpoint is the proportion of patients with an ACR20 response achieved by re-treatment at any time. [ Time Frame: following retreatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of patients achieving an ACR50 and ACR70 response at any time following treatment. [ Time Frame: following retreatment ] [ Designated as safety issue: No ]

Enrollment: 341
Study Start Date: March 2004
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rituximab
    1 g. rituximab i.v. on Day 1 and 15
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able and willing to give written informed consent and comply with the requirements of the study protocol.
  2. Patients with active rheumatoid arthritis who participated in WA17042/IDEC 102-20, have completed the Week 24 visit (in initial or rescue therapy) and continue in the post-treatment phase (wk 24-wk 104) of the study.
  3. Eligible for re-treatment by the following criteria:

    (i) Achieved at least 20% reduction in both SJC and TJC (at the same time) during any visit from Week 16 onwards (in either initial or rituximab rescue therapy), including visits in the post-treatment period.

    (ii) Swollen joint count (SJC) ≥ 8 (66 joint count) and tender joint count (TJC)≥ 8 (68 joint count).

  4. 16 weeks or more has passed since the patient's last rituximab infusion.
  5. Patients of reproductive potential (males and females) using a reliable means of contraception (e.g. contraceptive pill, IUD, physical barrier).

Exclusion Criteria:

Exclusion Criteria Related to RA:

  1. Patients who participated in WA17042/IDEC 102-20 but withdrew into the safety follow-up at any time pre or post wk 24.
  2. Previous rituximab non-responders (those patients who failed to achieve 20% reduction in both SJC and TJC at the same time during any visit from Week 16, in WA17042/IDEC 102-20 rituximab study). These patients will remain in their current study until completion or withdrawal.

Excluded Previous/Concomitant Medications:

  1. Concurrent treatment with any other DMARD (apart from methotrexate), or any anti-TNF-α, anti- IL-1 or other biologic therapies.
  2. Immunization with a live or attenuated vaccine (e.g. certain formulations of influenza vaccines) is specifically excluded during the study.

Exclusions for General Safety:

  1. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
  2. Evidence of any new or uncontrolled concomitant disease that may permanently exclude the patient from receiving the rituximab regimen at any time such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders.
  3. A positive pregnancy test.
  4. Intolerance or contra-indications to i.v. glucocorticosteroids.
  5. Patients with known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with i.v. anti-infectives within 4 weeks of entry into this protocol or completion of oral anti-infectives within 2 weeks prior to entry. Entry into this protocol and re-treatment may be reconsidered once the infection has fully resolved.
  6. Primary or secondary immunodeficiency (history of or currently active).
  7. Lack of peripheral venous access.

Laboratory Exclusion Criteria:

Patients may not enter this protocol to be re-treated until any of the following that are present have resolved.

  1. Serum creatinine > 1.4 mg/dL for women or 1.6 mg/dL for men.
  2. AST or ALT > 2.5 times upper limit of normal.
  3. Platelet count < 100,000/µL.
  4. Hemoglobin < 8.0 g/dL.
  5. Neutrophils < 1.5 × 103/µL.
  6. Patients who have entered the study and are found to be HBsAg negative, HBcAb positive must have a negative hepatitis B viral DNA (<29 IU/mL) and AST/ALT less than or equal to 2.5X ULN results within the last 12 weeks.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468377

Locations
United States, North Carolina
Research Site
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
Hoffmann-La Roche
Genentech
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00468377     History of Changes
Other Study ID Numbers: 102-21
Study First Received: April 30, 2007
Last Updated: November 23, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 22, 2014