Phase 3
N=232
A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00502996 ↗Enrolled (actual)
232
Serious AEs
5.2%
Results posted
Oct 2016
Primary outcome: Primary: Number of Participants With Any Adverse Event, Any Serious Adverse Event, and Death — 189; 12; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Methotrexate (Drug); rituximab [MabThera/Rituxan] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Adverse Event, Any Serious Adverse Event, and Death |
189; 12; 0 | — |
| PRIMARY Number of Participants With AEs According to Degree of Intensity |
170; 102; 30; 12 | — |
| PRIMARY Number of Participants With AEs Leading to Discontinuation and Any Drug Related AEs and SAEs |
97; 0; 2 | — |
| PRIMARY Number of Participants With AEs of Special Interest During the Study |
5; 12; 12 | — |
| SECONDARY Mean Values of Hematology Parameters at Screening and EOT Visit (Hemoglobin and Mean Corpuscular Hemoglobin Concentration) |
12.4; 12.8; 30.0; 30.9 | — |
| SECONDARY Mean Values of Hematology Parameters at Screening and EOT Visit (Hematocrit, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils) |
37.8; 38.9; 67.8; 65.1; 24.0; 25.6 | — |
| SECONDARY Mean Values of Hematology Parameter at Screening and EOT Visit (Mean Corpuscular Volume) |
85.8; 87.7 | — |
| SECONDARY Mean Values of Hematology Parameter at Screening and EOT Visit (Erythrocytes) |
4.5; 4.4 | — |
| SECONDARY Mean Values of Hematology Parameters at Screening and EOT Visit (Leucocytes and Platelets) |
8.6; 7.7; 351.6; 310.6 | — |
| SECONDARY Mean Values of Biochemistry Parameters at Screening and Visit 8 (Albumin and Glucose) |
3.9; 4.1; 86.1; 88.1 | — |
| SECONDARY Mean Values of Cholesterol, Uric Acid, Urea, Creatinine, Calcium, Total Bilirubin and Serum Total Proteins at Screening and EOT Visit. |
187.9; 196.6; 4.0; 4.0; 29.3; 30.2 | — |
| SECONDARY Mean Values of Potassium, Chlorine, Sodium, and Phosphorus at Screening and EOT Visit |
140.1; 140.4; 4.2; 4.2; 103.1; 103.3 | — |
| SECONDARY Mean Values of Aspartate Transaminase, Alanine Transaminase, Alkaline Phosphatase, and Lactic Dehydrogenase at Screening and EOT Visit |
21.6; 22.0; 24.1; 25.9; 137.7; 138.2 | — |
| SECONDARY Mean Duration of Morning Joint Stiffness |
120.1; 16.0; 19.9 | — |
| SECONDARY Mean Value of Painful Joints |
17.5; 3.8; 4.4 | — |
| SECONDARY Number of Participants With American College of Rheumatology (20, 50, and 70) Criteria |
1; 84; 88; 0; 50; 62 | — |
| SECONDARY Mean Value of Quality of Life (Health Assessment Questionnaire - Disease Index) |
2.6; 2.5; 1.25; 1.0 | — |
| SECONDARY Mean Values of C Reactive Protein |
28.0; 27.6; 13.6; 15.3 | — |
| SECONDARY Mean Values of Globular Sedimentation Velocity |
43.7; 41.1; 26.8; 24.6 | — |
| SECONDARY Mean Values of Pain and Activity Based on Visual Analogue Scale |
6.9; 6.9; 3.6; 3.0; 6.6; 5.9 | — |
| SECONDARY Mean Value of Inflamed Joints |
17.5; 3.8; 4.4 | — |
Summary
This single arm study will assess the safety of MabThera plus methotrexate in patients with rheumatoid arthritis who have had a lack of response to 1-5 DMARDs or biological agents. Patients will receive MabThera (1g i.v.) on days 1 and 15, concomitantly with methotrexate >=15mg p.o./week. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- rheumatoid arthritis >=6 months;
- lack of response to 1-5 DMARDs or biological agents;
- rheumatoid factor positive.
Exclusion Criteria
- other chronic inflammatory articular disease or systemic rheumatic disease;
- joint or bone surgery during 8 weeks prior to randomization;
- previous treatment with any cell-depleting therapy.
Data sourced from ClinicalTrials.gov (NCT00502996). 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.