Phase 3
Completed N=15
A Long-Term Extension Study of WA19926 on the Safety of Tocilizumab (RoActemra/Actemra) in Participants With Early Moderate to Severe Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01655381 ↗Enrolled (actual)
15
Serious AEs
6.7%
Results posted
Jan 2017
Primary outcomePrimary: Percentage of Participants With Any Adverse Event (AE) — 93.3; 6.7; 93.3; 80.0 percentage of 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 This can indicate results are unpublished — a known publication-bias signal.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 open-label, single arm, multicenter long-term extension study will evaluate the safety and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe rheumatoid arthritis who have completed the 104-week WA19926 core study. Eligible participants will receive tocilizumab 8 mg/kg intravenously every 4 weeks for up to 104 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Any Adverse Event (AE) |
93.3; 6.7; 93.3; 80.0; 0; 80.0 | — |
| SECONDARY Percentage of Participants With at Least One Clinical Remission Period |
100.0 | — |
| SECONDARY Percentage of Participants With at Least One Drug-Free Period |
13.3 | — |
| SECONDARY Cumulative Time of Remission Per Participant Over the Extension Study Period |
598.00 | — |
| SECONDARY Percentage of Participants With at Least 1 Rheumatoid Arthritis (RA) Flare |
40.0 | — |
| SECONDARY Time to RA Flare Following Remission or Drug-Free Remission |
289.0 | — |
| SECONDARY Change From Day 1 in DAS28-ESR Scores Over Time |
2.09; -0.43; -0.65; -0.03; -0.58; -1.02 | — |
| SECONDARY Change From Day 1 in Simplified Disease Activity Index (SDAI) Scores Over Time |
4.40; -1.70; 2.68; NA; -3.70; -2.90 | — |
| SECONDARY Change From Day 1 in Tender Joint Count Based on 28 Joints (TJC28) Over Time |
2.07; -0.87; 0.29; 1.00; 1.07; -1.77 | — |
| SECONDARY Change From Day 1 in Swollen Joint Count Based on 28 Joints (SJC28) Over Time |
0.33; 0.27; 0.50; 1.50; 0.29; 0.46 | — |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) Over Time |
10.0; 2.00; 2.50; 2.00; 2.00; 2.00 | — |
| SECONDARY C-reactive Protein (CRP) Level |
4.70; 2.00; 2.00; 0.85; 1.30; 2.00 | — |
| SECONDARY Participants' Global Assessment of Pain (VAS) Score |
11.00; 7.00; 9.00; 10.00; 8.00; 4.00 | — |
| SECONDARY Participants' Global Assessment of Disease Activity (VAS) Score |
13.00; 17.00; 18.50; 10.00; 7.50; 5.00 | — |
| SECONDARY Physicians' Global Assessment of Disease Activity (VAS) Score |
5.00; 6.00; 1.00; 5.00; 5.00; 6.00 | — |
| SECONDARY Percentage of Participants With Health Assessment Questionnaire Disability Index (HAQ-DI) Remission |
73.3; 66.7; 62.5; 60.0; 50.0; 60.0 | — |
| SECONDARY Percentage of Participants With Clinically Meaningful Improvement From Baseline in HAQ-DI |
33.3; 25.0; 40.0; 30.0; 30.0; 33.3 | — |
Eligibility Criteria
Inclusion Criteria
- Adult participants, >/= 18 years of age
- Participants who complete their last WA19926 core study visit (Week 104) and who may benefit from study drug treatment, at baseline or later if they are in remission DAS28 at Week 104 of WA19926, according to the Investigator's assessment
- No current or recent adverse event or laboratory finding preventing the use of the study drug dose of tocilizumab 8 mg/kg at baseline visit
- Women of childbearing potential must agree to use adequate contraception as defined by protocol during and up to 3 months after treatment
Exclusion Criteria
- Pregnant females
- Participants who have withdrawn prematurely from the WA19926 core study for any reason
- Treatment with any investigational agent or cell-depleting therapies since the last administration of study drug in WA19926
- Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent, or a T-cell costimulation modulator since the last administration of study drug in WA19926
- Immunization with a live/attenuated vaccine since the last administration of study drug in WA19926
- Diagnosis since last WA19926 visit (Week 104) of rheumatic autoimmune disease other than rheumatoid arthritis
- Diagnosis since last WA19926 visit (Week 104) of inflammatory joint disease other than rheumatoid arthritis
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, including tocilizumab and its excipients
- Evidence of severe uncontrolled concomitant disease or disorder
- Known active or history of recurrent infections
- Active tuberculosis requiring treatment in the previous 3 years
- History of alcohol, drug or chemical abuse since inclusion in the WA19926 study
Data sourced from ClinicalTrials.gov (NCT01655381). 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.