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A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Phase 4 trial testing rituximab [MabThera/Rituxan] in Rheumatoid Arthritis in 18 participants. Completed in 16 May 2012.
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 17 March 2008 |
| Primary completion | 16 May 2012 |
| Estimated completion | 16 May 2012 |
| Sites | 4 locations across Tunisia |
Hoffmann-La Roche — full company profile →
18 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| Rituximab | 11 |
| Group | Value | 95% CI |
|---|---|---|
| Rituximab | 7 |
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], participant's global assessment of disease activity \[visual analog scale: \[VAS\] 0 equals (=) no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to 10. Scores less than (\<) 2.6 indicate best disease control and scores greater than or equal to (≥) 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score \< 2.6. The average i
| Group | Value | 95% CI |
|---|---|---|
| Rituximab | -1.7 | ± 49.4 |
The DAS28 score is a measure of the participant's disease activity calculated using the TJC \[28 joints\], SJC \[28 joints\], participant's global assessment of disease activity \[VAS: 0 = no disease activity to 100 = maximum disease activity\] and the ESR for a total possible score of 0 to 10. Scores \< 2.6 indicate best disease control and scores ≥ 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score \< 2.6. An improvement of \>1.2 was considered to be clinically significant improvement.
| Group | Value | 95% CI |
|---|---|---|
| Rituximab | 75.0 |
Bone mineral density test was performed using x-ray radiation and the values of bone density were provided directly by the apparatus as grams per square centimeter (g/cm\^2) . T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis.
| Group | Value | 95% CI |
|---|---|---|
| Rituximab | -1.82 |
| Group | Value | 95% CI |
|---|---|---|
| Rituximab | -1.6 |
Time frame: AEs were recorded from the day of first infusion until the End of Study at 104 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Rituximab |
|---|---|---|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — |
| Persistent thrombopenia | Blood and lymphatic system disorders | — |
| Rectal bleeding | Gastrointestinal disorders | — |
| Ventricular Extra systolebigeminy | Cardiac disorders | — |
| Severe infusion reaction | Injury, poisoning and procedural complications | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | Rituximab |
|---|---|---|
| Hypertension | Blood and lymphatic system disorders | — |
| Blurred Vision | Eye disorders | — |
| Hyperglycemia | Endocrine disorders | — |
| Multi-sensitive Streptococcus Cystitis | Infections and infestations | — |
| Keratitis Secca | Skin and subcutaneous tissue disorders | — |
| Red Throat | General disorders | — |
| Vertigo | Ear and labyrinth disorders | — |
| Somnolence | General disorders | — |
| Influenza | Infections and infestations | — |
| Muscular Pain | Musculoskeletal and connective tissue disorders | — |
| Nocturnal Sweating | General disorders | — |
| Headache | General disorders | — |
| Dyspnea Stage 2 | Respiratory, thoracic and mediastinal disorders | — |
| Productive Cough-Yellow Expectorations | Respiratory, thoracic and mediastinal disorders | — |
| Pneumopathy Infection | Infections and infestations | — |
Most-reported serious reactions: Pulmonary embolism, Persistent thrombopenia, Rectal bleeding, Ventricular Extra systolebigeminy, Severe infusion reaction, Dyspnea.
Data from ClinicalTrials.gov NCT01000610 adverse events section.
In this open-label single arm study the safety and efficacy of Mabthera will be evaluated in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and background methotrexate (10-25mg po or sc weekly). After the initial study period of 24 weeks, eligible patients may receive up to 3 re-treatments with MabThera. The anticipated time on study treatment is 1-2 years and target sample size is \<50
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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