Phase 3
N=538
A Long-term Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients With Rheumatoid Arthritis
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00721123 ↗Enrolled (actual)
538
Serious AEs
37.0%
Results posted
Oct 2013
Primary outcome: Primary: Adverse Event (AE) Summary Over Time — 433; 390; 333; 294 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tocilizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Event (AE) Summary Over Time |
433; 390; 333; 294; 329; 55 | — |
| PRIMARY Summary Adverse Event Rates Over Time |
393.76; 286.17; 260.14; 249.84; 212.04; 12.54 | — |
| PRIMARY Overall Death Rate Over Time |
0.41 | — |
| SECONDARY Participants Showing Improvement in Rheumatoid Arthritis Symptoms Over Time, Through 264 Weeks |
63.2; 76.0; 81.2; 83.3; 82.2; 83.9 | — |
| SECONDARY Percentage of Participants Classified as Responders by Disease Activity Scores Over Time, Through 264 Weeks |
24.6; 43.0; 53.7; 54.9; 57.2; 60.6 | — |
| SECONDARY Percentage of Participants Classified as Responders by EULAR Response Over Time, Through 264 Weeks |
41.2; 56.6; 65.5; 70.9; 69.5; 71.0 | — |
| SECONDARY Change From Baseline in Scores for Swollen and Tender Joint Counts Over Time, Through 264 Weeks |
-11.7; -13.6; -15.6; -16.2; -16.2; -16.5 | — |
| SECONDARY Change From Baseline in Scores for Health Assessment Questionnaire - Disability Index Over Time, Through 264 Weeks |
-0.49; -0.53; -0.59; -0.61; -0.65; -0.62 | — |
| SECONDARY Change From Baseline in Scores for Patient's Global Assessment of Disease Activity Over Time, Through 264 Weeks |
-26.6; -30.3; -31.1; -31.6; -33.0; -32.9 | — |
| SECONDARY Change From Baseline in Scores for Physician's Global Assessment of Disease Activity Over Time, Through 264 Weeks |
-33.8; -38.1; -41.1; -43.2; -44.8; -44.4 | — |
| SECONDARY Change From Baseline in Scores for Patient's Level of Pain Over Time, Through 264 Weeks |
-23.7; -26.7; -28.0; -28.1; -29.5; -29.2 | — |
| SECONDARY Percentage of Participants With at Least a 5-point Improvement From Baseline in Quality of Life Measure for Fatigue Over Time, Through 264 Weeks |
66.0; 58.7; 61.5; 62.3; 60.0; 62.2 | — |
| SECONDARY Percentage of Participants With at Least a 5-point Improvement From Baseline in Quality of Life Using the 36-Item Short-Form Health Survey (SF-36) Over Time, Through 264 Weeks |
48.2; 46.2; 48.6; 49.9; 49.7; 49.1 | — |
Summary
This open-label, international multi-center extension study WA18695 was designed to assess the long term safety of tocilizumab in patients who had moderate to severe active rheumatoid arthritis (RA). Patients enrolled in the WA18695 study had previously received treatment in the 24-week, placebo-controlled, Phase III Study WA17822. Eligible patients were assigned to treatment with 8 mg/kg tocilizumab every 4 weeks for a maximum of 5 years.
Eligibility Criteria
Inclusion Criteria
- Patients who have completed participation in the Phase III study WA17822 (NCT00106548) in adult rheumatoid arthritis.
Exclusion Criteria
- Treatment with any investigational agent since the last administration of study drug in WA17822.
- Treatment with intravenous (IV) gammaglobulin, plasmapheresis, or Prosorba column since the last administration of study drug in WA17822.
- Treatment with an anti-tumor necrosis factor or anti-interleukin-1 agent, or a T cell costimulation modulator since the last administration of study drug in WA17822.
- Previous treatment with any cell-depleting therapies.
- Parenteral, intramuscular, or intra-articular corticosteroids within 6 weeks prior to baseline.
Data sourced from ClinicalTrials.gov (NCT00721123). 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.