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A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid Arthritis Who Completed Study WA19926

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01730456
First received: November 15, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This multicenter, open-label, single arm, long-term extension study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with early moderate to severe rheumatoid arthritis who completed the WA19926 core study. Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for up to 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, SINGLE ARM, LONG TERM EXTENSION STUDY OF WA19926 TO DESCRIBE SAFETY DURING TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH EARLY, MODERATE TO SEVERE RHEUMATOID ARTHRITIS

Resource links provided by NLM:

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 3 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 achieving sustained drug-free remission, defined as clinical remission based on DAS28-ESR <2.6 and/or SDAI </=3 for two consecutive visits (every 12 weeks) followed by RoActemra/Actemra discontinuation after the 2nd visit [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Time to rheumatoid arthritis flare in patients who have entered drug-free remission [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RoActemra/Actemra Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, up to 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 complete their last WA19926 core study visit (Week 104) and who may benefit from study drug treatment according to the Investigator's assessment
  • No current or recent adverse event or laboratory finding preventing the use of the study drug dose of RoActemra/Actemra 8 mg/kg at baseline visit
  • Receiving treatment on an outpatient basis
  • Females of childbearing potential must agree to use at least one adequate method of contraception, including a method with a failure rate of <1% per year, during the treatment period

Exclusion Criteria:

  • Pregnant or lactating women
  • Patients who have prematurely withdrawn from the WA19926 core study for any reason
  • Treatment with an investigational agent or cell-depleting therapies since the last administration of study drug in the WA19926 core study
  • Immunization with a live/attenuated vaccine since the last administration of study drug in the WA19926 core study
  • Diagnosis since last WA19926 visit (Week 104) of rheumatic autoimmune disease other than rheumatoid arthritis
  • Diagnosis since last WA19926 visit (Week 104) of inflammatory joint disease other than rheumatoid arthritis
  • Inadequate liver, hematologic or renal function
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  • Known active or history of recurrent infections
  • Evidence of active malignant disease, malignancies within the previous 10 years (except for basal cell carcinoma of the skin that has been excised and cured), or breast cancer diagnosed within the previous 20 years
  • Uncontrolled disease states, such as asthma or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730456

Locations
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
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: NCT01730456     History of Changes
Other Study ID Numbers: ML28133
Study First Received: November 15, 2012
Last Updated: May 7, 2013
Health Authority: Macedonia: Pharmaceutical Bureau, Ministry of Health

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 19, 2013