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: October 6, 2014
Last verified: October 2014
  Purpose

This multicenter, open-label, single arm, long-term extension study will evaluat e the safety and efficacy of RoActemra/Actemra in patients with moderate to seve re rheumatoid arthritis who have completed the 97-week WA22762 core study. Patie nts 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: September 2015
Estimated Primary Completion Date: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 6, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM)

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 20, 2014