Phase 2
Completed N=103
A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate
Source: ClinicalTrials.gov NCT00282308 ↗Enrolled (actual)
103
Serious AEs
4.7%
Results posted
Oct 2013
Primary outcomePrimary: Percentage of Patients With a Positive Immune Response to Tetanus Toxoid Adsorbed Booster Vaccine — 39.1; 42.3 Percentage of patients
Summary
This was a Phase II, randomized, open-label, multicenter study designed to evaluate the immune response to vaccines after administration of 1000 mg of rituximab in subjects with active rheumatoid arthritis (RA) who were receiving background methotrexate (MTX).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With a Positive Immune Response to Tetanus Toxoid Adsorbed Booster Vaccine |
39.1; 42.3 | — |
| SECONDARY Percentage of Patients With a 2-fold Increase in Tetanus Antibody Titers or With Tetanus Antibody Titers ≥ 0.2 IU/mL in Response to Tetanus Toxoid Adsorbed Booster Vaccine |
54.7; 61.5 | — |
| SECONDARY Percentage of Patients With a Positive Immune Response to Each of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine |
12.7; 42.9; 9.5; 28.6; 12.7; 60.7 | — |
| SECONDARY Percentage of Patients With a Positive Immune Response to at Least 50% (≥ 6 of 12) of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine |
19.0; 60.7 | — |
| SECONDARY Percentage of Patients With a Positive Immune Response to at Least k (for k = 1, 2, 3, 4, 5) of the 12 Anti-pneumococcal Antibody Serotypes in Response to the 23-valent Pneumococcal Polysaccharide Vaccine |
57.1; 82.1; 42.9; 82.1; 38.1; 78.6 | — |
| SECONDARY Serum Level of Anti-tetanus Antibody Measured Immediately Prior to and 4 Weeks After Administration of a Tetanus Toxoid Adsorbed Booster Vaccine |
1.2; 1.0; 4.0; 5.2 | — |
| SECONDARY Serum Level of Anti-pneumococcal Antibody Measured Immediately Prior to and 4 Weeks After Administration of a 23-valent Pneumococcal Polysaccharide Vaccine |
0.8; 1.0; 1.0; 2.3 | — |
| SECONDARY Serum Level of Anti-keyhole Limpet Hemocyanin Antibody Measured Immediately Prior to and 4 Weeks After the First Administration of Keyhole Limpet Hemocyanin |
345.7; 388.0; 539.5; 1585.5 | — |
| SECONDARY Percentage of Patients Who Maintained a Positive Response to the C. Albicans Skin Test From Day 1 to Week 24 for Group A or From Day 1 to Week 12 for Group B |
77.4; 70.0 | — |
| SECONDARY Percentage of Patients in Group A With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24 |
36.4; 21.2; 4.5 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-65 years.
- Diagnosis of rheumatoid arthritis (RA) for at least 6 months.
- Receiving treatment for RA on an outpatient basis.
- Use of methotrexate (MTX) at a dose of 10-25 mg/wk (oral [PO] or subcutaneous [SC]) for at least 12 weeks prior to Day 1, with the dose stable during the last 4 weeks prior to Day 1 (first day of the treatment period).
- If taking a background corticosteroid, use of the corticosteroid must be for at least 12 weeks prior to Day 1 at a stable dose during the last 4 weeks prior to Day 1.
- If taking one non-steroidal anti-inflammatory drug (NSAID), use of a stable dose for at least 2 weeks prior to Day 1.
Exclusion Criteria
- Rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA; Sjogren's syndrome with RA is permitted.
Data sourced from ClinicalTrials.gov (NCT00282308). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.