Phase 3
N=886
A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00891020 ↗Enrolled (actual)
886
Serious AEs
10.9%
Results posted
Apr 2012
Primary outcome: Primary: Percentage of Participants Experiencing at Least One Serious Adverse Event (SAE) During the 24 Week Treatment Period — 5.8; 8.0; 8.4 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- tocilizumab [RoActemra/Actemra] (Drug); Nonbiologic DMARDs of investigator's choice (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing at Least One Serious Adverse Event (SAE) During the 24 Week Treatment Period |
5.8; 8.0; 8.4 | — |
| SECONDARY Percentage of Participants Experiencing Serious Adverse Events of Special Interest |
2.9; 3.6; 3.9; 0; 0.8; 0 | — |
| SECONDARY Percentage of Participants Experiencing Non-serious Adverse Events of Special Interest |
0; 0; 0.3; 4.3; 3.3; 7.3 | — |
| SECONDARY Percentage of Participants Achieving Clinical Remission at Weeks 8, 16, and 24 |
8.8; 6.8; 12.9; 15.7; 17.4; 22.0 | — |
| SECONDARY Change From Baseline in DAS28 Score at Weeks 8, 16 and 24 |
-1.75; -1.00; -1.54; -2.07; -1.66; -1.87 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology (ACR) (ACR20/50/70) Responses at Weeks 8, 16, and 24 |
40.5; 37.8; 40.8; 14.7; 11.9; 16.8 | — |
| SECONDARY Percentage of Participants With Tocilizumab Dose Increased From 4 mg/kg to 8 mg/kg at Week 8 |
39.9 | — |
| SECONDARY Number of Participants Having Their Tocilizumab Dose Increased From 4 mg/kg to 8 mg/kg at Weeks 12, 16, and 20 |
41; 18; 5 | — |
| SECONDARY Change From Baseline in Routine Assessment Patient Index Data (RAPID3) Score at Weeks 8, 16, and 24 |
-1.60; -1.10; -1.28; -1.97; -1.42; -1.46 | — |
| SECONDARY Change From Baseline in Fatigue Visual Analogue Scale (VAS) at Weeks 8, 16, and 24 |
-13.17; -10.06; -13.33; -19.38; -14.00; -15.58 | — |
Summary
This 3 arm randomized open label study will evaluate the safety, tolerability and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis, who have had inadequate response to or are unable to tolerate DMARDs. The protocol incorporates risk mitigation strategies developed in partnership with the FDA to manage known and potential risks associated with the treatment of tocilizumab. Patients will be randomized to receive tocilizumab either 4 mg/kg intravenous (iv) or 8 mg/kg iv with concomitant non-biologic DMARDs, or 8 mg/kg iv without concomitant non-biologic DMARDs, every 4 weeks, for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is 500-1000 individuals.
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- moderate to severe active rheumatoid arthritis for >6 months;
- inadequate clinical response or unable to tolerate current or prior biologic or non-biologic Disease-modifying antirheumatic drug (DMARD) therapy;
- Swollen joint count (SJC) >/=4 and Tender joint count (TJC) >/=4
- body weight /= 7 weeks prior to baseline;
Exclusion Criteria
- history of autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
- functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in rheumatoid arthritis;
- treatment with rituximab within 6 months before screening;
- intraarticular corticosteroids within 8 weeks or intramuscular (im)/ intravenous (iv) corticosteroids within 12 weeks prior to screening;
- known active current or history of recurrent infections, or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening.
Data sourced from ClinicalTrials.gov (NCT00891020). 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.