A Long-Term Extension Study of WA22763 of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01734993
First received: November 19, 2012
Last updated: April 7, 2014
Last verified: April 2014
  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:


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 ]

Enrollment: 11
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Locations
France
Bordeaux, France, 33076
Montpellier, France, 34295
Nantes, France, 44035
Paris, France, 75679
Strasbourg, France, 67098
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: April 7, 2014
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 April 17, 2014