Phase 3
Completed N=286
A Study to Assess Efficacy With Respect to Clinical Improvement in Disease Activity and Safety of Tocilizumab in Patients Wtih Active Rheumatoid Arthritis.
Source: ClinicalTrials.gov NCT00754559 ↗Enrolled (actual)
286
Serious AEs
11.2%
Results posted
Jun 2014
Primary outcomePrimary: Percentage of Participants With Low Disease Activity Score at Week 24 — 57 Percentage of Participants — p=<0.001
Summary
This single arm study will assess the effectiveness of tocilizumab in combination with traditional DMARDs with regard to the clinical improvement in disease activity (achievement of LDAS) after 24 weeks' treatment in patients with active rheumatoid arthritis (RA) who have had an inadequate response to current traditional DMARD and/or anti-TNF therapy. Patients will receive tocilizumab 8mg/kg iv every 4 weeks, in addition to ongoing DMARDs at the stable pre-entry dose prescribed by the physician, for a total of 6 infusions during the regular treatment period and a further 6 infusions during an optional extension phase. The anticipated time on study treatment is 6 to 12 months, and the target sample size is <500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Low Disease Activity Score at Week 24 |
57 | <0.001 sig |
| SECONDARY Absolute Changes in DAS28 From Baseline |
-1.31; -2.1; -2.4; -2.8; -3.2; -3.2 | — |
| SECONDARY Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category |
54.9; 20.3; 24.8 | — |
| SECONDARY Percentage of Participants With a DAS28 Response at Weeks 4 and 24 |
75.2; 23.1; 76.6; 40.9; 74.5; 47.6 | — |
| SECONDARY Percentage of Participants With an American College of Rheumatology 20%, 50%, or 70% (ACR20/ACR50/ACR70) Response |
25.2; 7.0; 2.4; 41.3; 14.7; 4.9 | — |
| SECONDARY Change From Baseline in Swollen and Tender Joint Counts at Week 24 |
-9.6; -13.4 | — |
| SECONDARY Change From Baseline in the Levels of C-Reactive Protein at Week 24 |
-20.1 | — |
| SECONDARY Change From Baseline in Participant's Global Assessment of Pain (VAS) at Week 24 |
-36.2 | — |
| SECONDARY Change From Baseline in Participant and Physician Assessment of Global Disease Activity (VAS) at Week 24 |
-35.9; -44.9 | — |
| SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) Score |
-8.4; -13.3; -15.6; -19.7; -22.4; -22.4 | — |
| SECONDARY Change From Baseline in HAQ-DI at Week 24 |
-0.48 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24 |
8.6 | — |
| SECONDARY Change From Baseline in Short Form-36 (SF-36) Score at Week 24 |
18.4; 16.5; 25.0; 11.9; 18.0; 13.8 | — |
| SECONDARY Participant's Global Assessment of Pain as Assessed by Patient Take Home Form (PTHF) |
60.7; 48.6; 41.9; 36.3; -12.0; -18.7 | — |
| SECONDARY Duration of Morning Stiffness as Assessed Using PTHF |
2.4; 1.8; 1.5; 1.2; -0.6; -0.9 | — |
| SECONDARY Participant Assessment of Fatigue/Tiredness as Assessed Using PTHF |
52.9; 42.2; 36.3; 30.6; -10.6; -16.6 | — |
| SECONDARY Treatment Satisfaction Questionnaire for Medication (TSQM) Score |
69.4; 88.7; 72.4; 74.7 | — |
| SECONDARY Changes in Hemoglobin |
128.6; 132.2; 133.5; 133.5; 136.1; 3.5 | — |
| SECONDARY Changes in C-Reactive Protein |
23.1; 3.5; 2.4; 5.5; 3.0; -19.6 | — |
| SECONDARY Changes in Erythrocyte Sedimentation Rate (ESR) |
37.4; 16.7; 10.6; 10.3; 7.1; -20.6 | — |
| SECONDARY Percentage of Participants Withdrawing From Study Treatment Because of Insufficient Therapeutic Response |
4.0 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- rheumatoid arthritis of >=6 months duration diagnosed according to the revised 1987 ACR criteria;
- DAS28 of >3.2;
- At screening either ESR >=28 mm/h or CRP >=1 mg/dL;
- Having received permitted DMARDs, 1 or more; current DMARD therapy must have been at a stable dose for at least 8 weeks prior to baseline.
Exclusion Criteria
- major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following screening;
- functional class IV as identified by the ACR classification of functional status in RA;
- rheumatoid autoimmune disease other than RA;
- prior history of or current inflammatory joint disease other than RA.
Data sourced from ClinicalTrials.gov (NCT00754559). 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.