Phase 3
Completed N=11
A Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA).
Source: ClinicalTrials.gov NCT01734993 ↗Enrolled (actual)
11
Serious AEs
18.2%
Results posted
Nov 2016
Primary outcomePrimary: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 100; 18.2 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 This can indicate results are unpublished — a known publication-bias signal.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, interventional, long-term extension (LTE) study will evaluate the safety and efficacy of tocilizumab (TCZ, RoActemra/Actemra) in French participants with moderate to severe RA who have completed the Week 97 visit of WA22762 LTE study (NCT01194414) (EudraCT Number 2010-018375-22). Participants from France, who completed the Week 97 visit of the WA22762 LTE study and considered as responders (defined as having improvement in disease activity score based on 28-joint count [DAS28] of greater than [>] 1.2 points) will continue TCZ treatment within this local LTE study for a maximum of 156 weeks of subcutaneous (SC) TCZ treatment, or until SC TCZ becomes commercially available, whichever occurs first.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
100; 18.2 | — |
| PRIMARY Percentage of Participants With AEs and SAEs Related to TCZ |
72.7; 9.1 | — |
| PRIMARY Percentage of Participants With Adverse Events of Special Interest (AESIs) |
18.2 | — |
| PRIMARY Percentage of Participants With AESIs Related to TCZ |
18.2 | — |
| PRIMARY Percentage of Participants With AEs Leading to TCZ Discontinuation, Interruption, or Dose Modification |
9.1; 63.6; 0.0 | — |
| PRIMARY Percentage of Participants With Clinically Significant Physical Examinations and Vital Signs Abnormalities |
0.0 | — |
| PRIMARY Percentage of Participants With Clinically Significant Laboratory Abnormalities |
9.1 | — |
| PRIMARY Percentage of Participants With Anti-TCZ Antibodies |
0.0 | — |
| SECONDARY Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score |
1.81; 0.16; -0.14; -0.02; -0.32; -0.33 | — |
| SECONDARY Change From Baseline in Simplified Disease Activity Index (SDAI) Score |
7.21; 9.17; 8.48; 4.50; -1.02; -1.02 | — |
| SECONDARY Change From Baseline in TJC |
1.27; 0.50; 1.20; 1.00; 0.50; 1.20 | — |
| SECONDARY Change From Baseline in SJC |
1.00; 0.50; -0.50; -0.60; -0.80; -0.70 | — |
| SECONDARY Percentage of Participants With Clinical Remission |
90; 75 | — |
| SECONDARY Percentage of Participants With Concomitant Corticosteroid Discontinuation |
16.7 | — |
| SECONDARY Percentage of Participants With Concomitant Corticosteroid Dose Reduction |
50 | — |
| SECONDARY Time to Concomitant Corticosteroid Discontinuation |
472.00 | — |
| SECONDARY Time to Concomitant Corticosteroid Dose Reduction |
75 | — |
| SECONDARY Change From Baseline in PtGA of Disease Activity |
17.55; 11.82; 4.00; 0.90; -4.89; -0.89 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Pain |
19.18; 10.91; 3.80; -1.90; -6.44; -3.78 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score |
0.77; -0.20; 0.18; -0.07; 0.00; -0.13 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity |
11.00; 17.60; 5.22; 2.22; -4.11; -2.13 | — |
| SECONDARY Change From Baseline in ESR |
5.82; -2.44; -3.11; 1.89; 0.90; -0.10 | — |
| SECONDARY Change From Baseline in CRP |
0.49; 1.07; -0.25; -0.02; -0.05; -0.09 | — |
Eligibility Criteria
Inclusion Criteria
- Negative pregnancy test at screening and baseline
- Participants who have completed the 97-week WA22762 LTE study on SC or intravenous (IV) TCZ and who experienced, at any time during WA22762, clinically significant improvement in DAS28 (>1.2 points), and based on the investigator's judgment may continue to benefit from TCZ treatment in this study investigating the SC formulation
- No current or recent adverse events or laboratory findings preventing the use of the study drug dose of TCZ 162 mg SC at baseline visit
- 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 during the study and for at least 3 months following the last dose of study drug
- Oral corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDS) up to the recommended dose are permitted if on stable dose regimen for greater than and equal to (>/=) 4 weeks prior to baseline
- Permitted non-biological disease-modifying anti-rheumatic drugs (DMARDs) are allowed
Exclusion Criteria
- Participants who have prematurely withdrawn from the WA22762 LTE study for any reason
- Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies
- Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent, or a T-cell co stimulation modulator since the last administration of study drug in the WA22762 LTE study
- Immunization with a live/attenuated vaccine since the last administration of study drug in the WA22762 LTE study
- Diagnosis, since last WA22762 visit (Week 97), of rheumatic autoimmune disease other than rheumatoid arthritis; secondary Sjörgen's syndrome with RA is permitted
- Diagnosis, since last WA22762 visit (Week 97), of inflammatory joint disease other than RA
- Uncontrolled disease states, such as asthma or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids
- Evidence of serious uncontrolled concomitant disease
- Known active current or history of recurrent infection
- Primary or secondary immunodeficiency (history of or currently active)
- Body weight >150 kilograms (kg)
- Pregnant or lactating women
- Inadequate hematologic, renal or liver function
- History of alcohol, drug or chemical abuse within 1 year prior to screening
Data sourced from ClinicalTrials.gov (NCT01734993). 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.