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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00468377
• Date of registration: 30/04/2007
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: Safety and Efficacy Study of Re-treatment With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Respond Poorly to Anti-TNFa Therapies
• Scientific 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-TNFa Therapies
• Date of first enrolment: March 2004
• Target sample size: 341
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00468377
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

United States

Key inclusion & exclusion 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-a, 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: Rituximab

Primary Outcome(s)

The primary endpoint is the proportion of patients with an ACR20 response achieved by re-treatment at any time. [Time Frame: following retreatment]

Secondary Outcome(s)

The proportion of patients achieving an ACR50 and ACR70 response at any time following treatment. [Time Frame: following retreatment]

Secondary ID(s)

102-21

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Genentech, Inc.