Phase 3
Completed N=1,681
An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.
Source: ClinicalTrials.gov NCT00750880 ↗Enrolled (actual)
1,681
Serious AEs
7.8%
Results posted
Aug 2014
Primary outcomePrimary: Percentage of Participants With Adverse Events (AEs): Overall Summary — 77.4; 58.4; 7.8; 7.8 percentage of participants
Summary
This open-label, single arm study will investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biologic disease modifying antirheumatic drugs (DMARDs), in patients with severe active RA. Patients will receive tocilizumab 8mg/kg iv as a 60 minute infusion 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 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs): Overall Summary |
77.4; 58.4; 7.8; 7.8; 3.5; 5.1 | — |
| SECONDARY Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit |
1.1; 0.2; 27.6; 14.9; 49.2; 32.6 | — |
| SECONDARY Time to Low Disease Activity or Remission Based on DAS28 - Number of Participants With an Event |
1320; 1127 | — |
| SECONDARY Time to Low Disease Activity and Remission Based on DAS28 Score - Time to Event |
63.0; 112.0 | — |
| SECONDARY Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit |
24.7; 52.6; 22.7; 44.7; 40.8; 14.5 | — |
| SECONDARY DAS28 Scores by Visit |
5.96; 4.12; -1.84; 3.35; -2.60; 3.03 | — |
| SECONDARY Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit |
36.5; 10.5; 2.7; 0.3; 55.6; 26.9 | — |
| SECONDARY Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response - Number of Participants With an Event |
1431; 1075; 659; 232 | — |
| SECONDARY Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response |
57.0; 84.0; 90.0; 113.0 | — |
| SECONDARY Swollen Joint Count by Visit |
12.76; 9.24; -3.52; 6.56; -6.20; 5.62 | — |
| SECONDARY Tender Joint Count by Visit |
22.82; 16.55; -6.27; 12.21; -10.61; 10.47 | — |
| SECONDARY Patient's Global Assessment of Disease Activity by Visit |
62.52; 47.20; -15.32; 37.95; -24.52; 33.27 | — |
| SECONDARY Physician's Global Assessment of Disease Activity by Visit |
58.82; 39.79; -18.93; 30.01; -28.65; 25.71 | — |
| SECONDARY Patient's Global Assessment of Pain by Visit |
57.51; 43.10; -14.41; 34.93; -22.51; 31.02 | — |
| SECONDARY C-Reactive Protein by Visit |
1.94; 0.52; -1.40; 0.36; -1.59; 0.28 | — |
| SECONDARY Erythrocyte Sedimentation Rate by Visit |
39.20; 13.13; -26.07; 10.26; -28.93; 8.97 | — |
| SECONDARY HAQ-DI Scores by Visit |
1.49; 1.27; -022; 1.12; -0.37; 1.03 | — |
| SECONDARY Short Form-36 (SF-36) Physical Functioning Domain Scores by Visit |
31.39; 34.17; 2.79; 36.39; 4.95; 37.69 | — |
| SECONDARY Percentage of Participants With HAQ-DI Clinical Remission and Clinically Meaningful Improvement By Visit |
5.9; 12.6; 47.7; 19.0; 60.4; 23.9 | — |
| SECONDARY Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit |
25.91; 30.95; 5.01; 33.51; 7.50; 34.98 | — |
Eligibility Criteria
Inclusion Criteria
- male and non-pregnant or nursing female patients >=18 years of age;
- body weight =3.2) of >=6 months duration;
- on >=1 non-biologic DMARDs at a stable dose for a period of >= 8 weeks prior to start of treatment;
- inadequate clinical response to a stable dose of non-biologic DMARD or anti-TNF therapy;
- if receiving oral corticosteroids, the dose must have been stable for at least 25 of 28 days prior to start of treatment.
Exclusion Criteria
- major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment;
- rheumatic autoimmune disease other than RA;
- prior history of, or current inflammatory joint disease other than RA;
- functional class IV as defined by the ACR Classification of Functional Status in RA.
Data sourced from ClinicalTrials.gov (NCT00750880). 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.