A Long-Term Extension Study of WA22763 of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis
Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: tocilizumab [RoActemra/Actemra] (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s): Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche
Summary
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.
Clinical Details
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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Long-term safety: Incidence of adverse events
Secondary outcome: Change in disease activity: Disease Activity Score 28 - erythrocyte sedimentation rate (DAS28-ESR) and/or Simplified Disease Activity Index (SDAI)Change in total tender joint count (TJC) / swollen joint count (SJC) Proportion of patients with remission (DAS28 <2.6 or SDAI =3.3) at Weeks 52 and 104 Proportion of patients with corticosteroid dose reductions and/or discontinuation
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Bordeaux 33076, France
Montpellier 34295, France
Nantes 44035, France
Paris 75679, France
Strasbourg 67098, France
Toulouse 31059, France
Additional Information
Starting date: November 2012
Last updated: August 17, 2015
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