Phase 4
Completed N=32
A Study of Tocilizumab With or Without Methotrexate in Patients With Rheumatoid Arthritis.
Source: ClinicalTrials.gov NCT01010503 ↗Enrolled (actual)
32
Serious AEs
9.4%
Results posted
Aug 2014
Primary outcomePrimary: Percentage of Participants Adherent to Original Treatment — 93.75 percentage of participants
Summary
This open-label, single-arm, non-randomized study will evaluate the adherence and persistence to tocilizumab therapy in patients with moderate to severe active rheumatoid arthritis, who have an inadequate clinical response to non-biologic DMARDs. Patients will receive tocilizumab 8 mg/kg as intravenous infusion once every 4 weeks in combination with methotrexate or in case of intolerance to methotrexate as monotherapy. The anticipated time of study treatment is 6 months. The target sample size is 20-50 patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Adherent to Original Treatment |
93.75 | — |
| PRIMARY Percentage of Participants Receiving Less Than or Equal to (≤) 1 Dose of Study Drug Who Discontinued Treatment for Any Reason |
3.13 | — |
| PRIMARY Percentage of Participants Receiving Greater Than (>) 1 Dose Who Discontinued Treatment for Any Reason |
— | — |
| PRIMARY Percentage of Participants Withdrawing From the Study Prematurely for Any Reason |
6.25 | — |
| PRIMARY Percentage of Participants With Dose Reduction to Tocilizumab 4 mg/kg |
18.75 | — |
| SECONDARY Disease Activity Score Based on 28-Joint Count (DAS28) |
7.02; 4.30; 2.85; 2.57 | — |
| SECONDARY Patient Global Assessment of Pain |
59.91; 36.31; 22.3; 17.30; 18.93; 16.73 | — |
| SECONDARY Patient Global Assessment of Disease Activity |
61.75; 35.59; 22.20; 18.20; 18.80; 18.13 | — |
| SECONDARY Physician's Global Assessment of Disease Activity |
59.63; 27.75; 17.40; 14.20; 13.00; 12.77 | — |
| SECONDARY Swollen Joint Count (SJC) |
26.66; 12.03; 7.00; 5.33; 5.33; 4.20 | — |
| SECONDARY Tender Joint Count (TJC) |
16.16; 5.53; 1.97; 1.30; 1.00; 0.83 | — |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) |
55.81; 16.69; 15.23; 14.17; 11.00 | — |
| SECONDARY C-Reactive Protein (CRP) |
17.84; 5.03; 5.54; 6.71; 2.97 | — |
| SECONDARY Health Assessment Questionnaire - Disability Index (HAQ-DI) Score |
1.77; 1.56; 1.31; 1.28; 1.23; 1.20 | — |
| SECONDARY Short Form-36 (SF-36) |
26.08; 44.50; 47.22; 6.25; 49.17; 44.44 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients >/= 18 years of age
- moderate to severe active rheumatoid arthritis
- inadequate response, or intolerance to previous therapy with one or more traditional DMARDs
- DAS >3.6
- pneumology examination (including chest x-ray and quantiferon)
Exclusion Criteria
- < 18 years of age
- active infection
- active tuberculosis
- uncontrolled hyperlipoproteinaemia
- demyelinating disorders
- concomitant anti-TNF drugs
- history of intestinal ulceration and diverticulitis
Data sourced from ClinicalTrials.gov (NCT01010503). 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.