Phase 3
Completed N=23
A Long Term Extension Study of WA19926 (NCT01007435) of Tocilizumab (RoActemra/Actemra) in Participants With Early, Moderate to Severe Rheumatoid Arthritis (RA)
Source: ClinicalTrials.gov NCT01668966 ↗Enrolled (actual)
23
Serious AEs
9.5%
Results posted
May 2019
Primary outcomePrimary: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 95.2; 9.5 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 This can indicate results are unpublished — a known publication-bias signal.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 of WA19926 (NCT01007435) will evaluate the safety and efficacy of tocilizumab in participants with early, moderate to severe RA who have completed the 104-week WA19926 (NCT01007435) core study. Eligible participants will be those who are expected to benefit from the study medicine based on the investigator's discretion.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
95.2; 9.5 | — |
| PRIMARY Percentage of Participants With TEAEs of Special Interest |
95.2 | — |
| PRIMARY Percentage of Participants With TEAEs Leading to Change in Dose or Study Drug Discontinuation |
4.8; 28.6 | — |
| SECONDARY Change From Baseline (CFB) in Disease Activity Score 28 Using Erythrocyte Sedimentation Rate (DAS28-ESR) at Specified Time Points |
2.4; -0.6; -0.6; -0.5; -0.6; -0.5 | 0.101 |
| SECONDARY CFB in Simplified Disease Activity Index (SDAI) Score at Specified Time Points |
9.5; -2.4; -2.7; -2.8; -3.0; -3.2 | 0.1853 |
| SECONDARY CFB in Swollen Joint Count (SJC) at Specified Time Points |
0.8; -1.3; -1.6; -1.5; -0.9; -1.8 | 0.0624 |
| SECONDARY CFB in Tender Joint Count (TJC) at Specified Time Points |
5.8; -3.1; -4.8; -5.4; -5.9; -6.0 | 0.2388 |
| SECONDARY Percentage of Participants Reaching Clinical Remission (DAS28-ESR Score Less Than [<] 2.6 and/or SDAI Score Less Than or Equal to [</=] 3.3) Among Participants for Whom Tocilizumab Treatment Was Discontinued |
100; 100 | — |
| SECONDARY Time to RA Crisis Among Participants Who Discontinued After Clinical Remission |
135.3 | — |
| SECONDARY CFB in PGA of Disease Activity Using VAS Score at Specified Time Points |
26.5; -0.3; 2.5; 2.0; 0.4; -0.5 | 0.934 |
| SECONDARY CFB in PGA of Pain Using VAS Score at Specified Time Points |
22.3; 2.5; 5.0; 3.6; 0.6; 1.0 | 0.445 |
| SECONDARY CFB in PhGA of Disease Activity Using VAS Score at Specified Time Points |
7.9; -1.0; -0.8; -1.0; 0.8; -2.2 | 0.565 |
| SECONDARY CFB in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score at Specified Time Points |
4.38; 1.60; -0.10; 0.05; -1.05; -0.65 | 0.3299 |
Eligibility Criteria
Inclusion Criteria
- Participants who completed their last WA19926 (NCT01649804) core study visit (Week 104) and who may benefit from study drug treatment according to the Investigator's assessment
- No current or recent adverse event or laboratory finding preventing the use of tocilizumab 8 mg/kg at baseline visit
- Women of childbearing potential must agree to use highly reliable contraception during the treatment period
Exclusion Criteria
- Pregnant or breastfeeding females
- Participants who have withdrawn prematurely from the WA19926 (NCT01649804) core study for any reason
- Treatment with any investigational agent or cell-depleting therapies since the last administration of study drug in WA19926 (NCT01649804)
- 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 (NCT01649804)
- Immunization with a live/attenuated vaccine since the last administration of study drug in WA19926 (NCT01649804)
- Diagnosis since last WA19926 (NCT01649804) visit (Week 104) of rheumatic autoimmune disease other than RA
- Diagnosis since last WA19926 (NCT01649804) visit (Week 104) of inflammatory joint disease other than RA
- 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 infections 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 (NCT01649804) study
Data sourced from ClinicalTrials.gov (NCT01668966). 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.