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: August 4, 2014
Last verified: August 2014

November 15, 2012
August 4, 2014
October 2012
February 2015   (final data collection date for primary outcome measure)
Long-term safety: Incidence of adverse events [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01730456 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid Arthritis Who Completed Study WA19926
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

This multicenter, open-label, single arm, long-term extension study will evaluat e the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with ea rly moderate to severe rheumatoid arthritis who completed the WA19926 core study Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks fo r up to 104 weeks.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, up to 104 weeks
Experimental: RoActemra/Actemra
Intervention: Drug: tocilizumab [RoActemra/Actemra]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
13
February 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Macedonia, The Former Yugoslav Republic of
 
NCT01730456
ML28133
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP