Phase 4
Completed N=26
A Long-term Safety Extension Study of Tocilizumab in Brazilian Participants With Rheumatoid Arthritis (RA) Who Completed the Studies ML21530 and MA21488
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT01715831 ↗
Enrolled (actual)
26
Serious AEs
15.4%
Results posted
Jun 2017
Primary outcomePrimary: Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (NSAEs) — 4; 24 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This multicenter, open-label, single-arm extension study will evaluate the long-term safety of tocilizumab (RoActemra/Actemra) in participants with RA. Participants who have completed the MA21488 (NCT00810199) core study and the ML21530 (NCT00754572) study and who could benefit from the study drug, according to the opinion of the investigator, will receive 8 milligrams per kilogram (mg/kg) of intravenous (IV) tocilizumab every 4 weeks. The anticipated time on study treatment is 104 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (NSAEs) |
4; 24 | — |
| PRIMARY Number of Participants With AEs Leading to Dose Modification or Study Discontinuation |
7; 1 | — |
| PRIMARY Number of Participants With AEs of Special Interest |
— | — |
| SECONDARY Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) |
2.76; 2.23; 2.43; 2.04; 2.32; 1.82 | — |
| SECONDARY Tender Joint Count (TJC) |
2.8; 1.8; 2.0; 1.9; 2.8; 1.1 | — |
| SECONDARY Swollen Joint Count (SJC) |
1.4; 1.0; 0.6; 0.9; 1.4; 0.8 | — |
| SECONDARY Global Evaluation of Disease Activity by the Participant Using VAS Score |
35.2; 36.4; 38.4; 31.8; 32.8; 30.6 | — |
| SECONDARY Global Evaluation of Disease Activity by the Physician Using VAS Score |
20.6; 11.4; 13.8; 13.1; 9.1; 13.0 | — |
| SECONDARY Participant's Pain Assessment Using VAS Score |
31.9; 29.0; 33.7; 28.6; 27.8; 27.4 | — |
| SECONDARY Health Assessment Questionnaire - Disability Index (HAQ-DI) Score |
0.68; 0.49; 0.49; 0.49; 0.48; 0.53 | — |
| SECONDARY Health Assessment Questionnaire (HAQ) Pain VAS Score |
31.9; 30.8; 37.8; 30.1; 32.7; 31.3 | — |
| SECONDARY C-Reactive Protein (CRP) Level |
0.51; 3.13; 1.08; 2.58; 0.21; 0.41 | — |
| SECONDARY ESR Level |
9.8; 4.9; 8.5; 4.6; 5.1; 4.9 | — |
Eligibility Criteria
Inclusion Criteria
- Participants who have completed their last visit in the core studies ML21530 and MA21488 and that might benefit from treatment using the study drug according to the investigator's evaluation
- Absence of an AE or current or recent laboratory finding that would prevent the use of the 8 mg/kg dose of the tocilizumab
- Receiving outpatient treatment
- For women who are not postmenopausal and are not surgically sterile: agreement to use at least one adequate method of contraception
Exclusion Criteria
- Participants who have prematurely discontinued the core studies ML21530 and MA21488 for any reason
- MA21488 study participants who remained untreated with tocilizumab after it's discontinuation according to the treatment-free remission criteria of MA21488 study
- Immunization with a live/attenuated vaccine since the last administration of the study drug in the core studies ML21530 and ML21488
- Diagnosis after the last visit of the study ML21530 or after the last visit of the study MA21488 of a rheumatic autoimmune disease other than RA, including systemic erythematous lupus (SEL), mixed connective tissue disease (MCTD), scleroderma and polymyositis, or a significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis or Felty's syndrome). Secondary Sjogren's Syndrome and/or nodulosis with RA are allowed
- Diagnosis after the last visit of the core study ML21530 or of the study MA21488 of an inflammatory joint disease other than RA
- Abnormal laboratory parameters at the baseline
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- Evidences of a concomitant, serious and uncontrolled illness
- Known active condition or a history of recurrent infections by bacteria, viruses, fungi, mycobacteria or other agents
- Evidence of an active malignant disease, malignancies diagnosed in the last 10 years or breast cancer diagnosed in the last 20 years
- Uncontrolled disease status, such as asthma or inflammatory bowel disease in which acute crises are usually treated with oral or parenteral corticosteroids
- Current hepatic disease, as determined by the investigator
- Active tuberculosis (TB) requiring treatment in the previous three years. Participants should be screened for latent TB according to local practice guidelines and should not be admitted into the study if latent TB is detected. Participants must not present any evidence of active TB infection at the enrollment. Participants treated for tuberculosis without recurrence in three years are allowed
- History of alcohol, drugs or chemical abuse since the inclusion in the core studies ML21530 and MA21488
Data sourced from ClinicalTrials.gov (NCT01715831). 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.