Phase 3
Completed N=47
A Long-Term Extension Study of WA22763 and NA25220 of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01772316 ↗Enrolled (actual)
47
Serious AEs
6.4%
Results posted
Aug 2016
Primary outcomePrimary: Percentage of Participants With an Adverse Event (AE) — 83 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 This can indicate results are unpublished — a known publication-bias signal.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 multicenter, open-label, single arm, long-term extension study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in participants with moderate to severe rheumatoid arthritis who have completed the 97-week WA22762 or the 96-week NA25220 core study. Participants will receive RoActemra/Actemra 162 milligram (mg) subcutaneously weekly (for participants entering from WA22762) or every two weeks (for participants entering from NA25220) for 96 weeks, with telephone call follow-up visits at Weeks 100 and 104.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Adverse Event (AE) |
83 | — |
| PRIMARY Percentage of Participants Withdrawn From the Study Due to Lack of Therapeutic Response |
— | — |
| PRIMARY Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 48 |
2.9; -0.832 | — |
| PRIMARY Change From Baseline in DAS28-ESR at Week 96 |
-0.804 | — |
| PRIMARY Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 48 |
12.2; -7.572 | — |
| PRIMARY Change From Baseline in SDAI at Week 96 |
-6.599 | — |
| PRIMARY Change From Baseline in Total Tender Joint Count (TJC) at Week 48 |
2.5; 1.3 | — |
| PRIMARY Change From Baseline in Total TJC at Week 96 |
1.5 | — |
| PRIMARY Change From Baseline in Swollen Joint Count (SJC) at Week 48 |
1.8; -1.531 | — |
| PRIMARY Change From Baseline in SJC at Week 96 |
-1.188 | — |
| SECONDARY Percentage of Participants With Remission (DAS28 <2.6 or SDAI </=3.3) at Weeks 48 and 96 |
71.9; 62.5; 28.6; 29.6 | — |
| SECONDARY Percentage of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs)/Corticosteroid Dose Reductions and/or Discontinuation |
38.2 | — |
| SECONDARY Patient Global Visual Analog Score (VAS) at Specified Time Points |
30.8; 30.0; 26.0 | — |
| SECONDARY Patient Pain VAS Score at Specified Time Points |
32.4; 29.8; 27.0 | — |
| SECONDARY Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Specified Time Points |
0.8; 0.7; 0.8 | — |
Eligibility Criteria
Inclusion Criteria
- Adult participants, >/= 18 years of age
- Participants who have completed the 97-week WA22762 or 96-week NA25220 core study on subcutaneous or intravenous RoActemra/Actemra and based on the investigator's judgment may continue to benefit from RoActemra/Actemra treatment in this study investigating the subcutaneous formulation
- Oral corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDS) up to the maximum recommended dose are permitted if on a stable dose regimen for >/= 4 weeks prior to baseline
- Permitted non-biological disease-modifying anti-rheumatic drugs (DMARDs) are allowed
- Receiving treatment on an outpatient basis
- Females of childbearing potential and males with female partners of childbearing potential must agree to use reliable means of contraception
Exclusion Criteria
- Participants who have prematurely withdrawn from the WA22762 or NA25220 core studies for any reason
- Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies
- History of severe allergic or anaphylactic reactions to human, humanized or mural monoclonal antibodies
- Evidence of serious uncontrolled concomitant disease
- Current liver disease as determined by the principal investigator
- History of diverticulitis, diverticulosis requiring antibiotic treatment or chronic ulcerative lower gastrointestinal (GI) disease such as Crohn's disease, ulcerative colitis or other symptomatic lower GI conditions that might predispose to perforations
- Known active current or history of recurrent infections
- Any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
- Active tuberculosis requiring treatment within the previous 3 years
- Primary or secondary immunodeficiency (history of or currently active)
- Pregnant or breast feeding women
- Body weight > 150 kilogram (kg)
- Inadequate renal, hepatic or hematologic function
- Positive for hepatitis B or hepatitis C
Data sourced from ClinicalTrials.gov (NCT01772316). 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.