A Long-Term Extension Study of WA22763 of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01734993
First received: November 19, 2012
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
This multicenter, open-label, single arm, long-term extension study will evaluate the safety and efficacy of RoActemra/Actemra in patients with moderate to severe rheumatoid arthritis who have completed the 97-week WA22762 core study. Patients will receive RoActemra/Actemra 162 mg subcutaneously weekly for 104 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: tocilizumab [RoActemra/Actemra] |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A MULTICENTER, OPEN-LABEL LONG-TERM EXTENSION STUDY OF WA22762 TO EVALUATE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS |
Resource links provided by NLM:
MedlinePlus related topics:
Rheumatoid Arthritis
Drug Information available for:
Tocilizumab
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Long-term safety: Incidence of adverse events [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in disease activity: Disease Activity Score 28 - erythrocyte sedimentation rate (DAS28-ESR) and/or Simplified Disease Activity Index (SDAI) [ Time Frame: from baseline to Week 104 ] [ Designated as safety issue: No ]
- Change in total tender joint count (TJC) / swollen joint count (SJC) [ Time Frame: from baseline to Week 104 ] [ Designated as safety issue: No ]
- Proportion of patients with remission (DAS28 <2.6 or SDAI </=3.3) at Weeks 52 and 104 [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
- Proportion of patients with corticosteroid dose reductions and/or discontinuation [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 17 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: RoActemra/Actemra SC |
Drug: tocilizumab [RoActemra/Actemra]
162 mg subcutaneously weekly, 104 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Patients who have completed the 97-week WA22762 core study on subcutaneous or intravenous RoActemra/Actemra 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 RoActemra/Actemra treatment in this study investigating the subcutaneous formulation
- No current or recent adverse events or laboratory findings preventing the use of the study drug dose of RoActemra/Actemra 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 >/= 4 weeks prior to baseline
- Permitted non-biological disease-modifying anti-rheumatic drugs (DMARDs) are allowed
Exclusion Criteria:
- Patients who have prematurely withdrawn from the WA22762 core 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 costimulation modulator since the last administration of study drug in the WA22762 core study
- Immunization with a live/attenuated vaccine since the last administration of study drug in the WA22762 core study
- Diagnosis since last WA22762 visit (Week 97) of rheumatic 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 rheumatoid arthritis
- 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 kg
- Pregnant or lactating women
- Inadequate hematologic, renal or liver function
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734993
Contacts
| Contact: Please reference Study ID Number: ML28544 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| France | |
| Active, not recruiting | |
| Bordeaux, France, 33076 | |
| Recruiting | |
| Montpellier, France, 34295 | |
| Active, not recruiting | |
| Paris, France, 75679 | |
| Active, not recruiting | |
| Strasbourg, France, 67098 | |
| Active, not recruiting | |
| Toulouse, France, 31059 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01734993 History of Changes |
| Other Study ID Numbers: | ML28544 |
| Study First Received: | November 19, 2012 |
| Last Updated: | May 7, 2013 |
| Health Authority: | France: Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013