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A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01089023
Recruitment Status : Completed
First Posted : March 18, 2010
Results First Posted : July 22, 2014
Last Update Posted : July 22, 2014
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE March 8, 2010
First Posted Date  ICMJE March 18, 2010
Results First Submitted Date  ICMJE June 23, 2014
Results First Posted Date  ICMJE July 22, 2014
Last Update Posted Date July 22, 2014
Study Start Date  ICMJE January 2010
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2014)
Percentage of Participants Reporting Any Adverse Event - Overall Summary of Events [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24 ]
Percentage of participants with a serious adverse event (SAE), who died, with an adverse event (AE), or study drug related AE during the study.
Original Primary Outcome Measures  ICMJE
 (submitted: March 17, 2010)
Safety and Tolerability: AEs, laboratory parameters [ Time Frame: AEs: event-driven assessments throughout study, laboratory assessments every 4 weeks for 24 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2014)
  • Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24 ]
    DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and global health assessment (participant rated global assessment of disease activity using 10-mm Visual analog scale - VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. A DAS28 score of greater than (>)5.1 indicated high disease activity, a score of >3.2 but less than or equal to (≤)5.1 indicated moderate disease activity, a score of greater than or equal to (≥)2.6 but ≤3.2 indicated low disease activity, and a score of less than <2.6 indicated disease remission. Week 24 is the Follow-Up visit.
  • Percentage of Participants Achieving a Clinically Meaningful Improvement as Measured by DAS28 [ Time Frame: Weeks 4, 8, 12, 16, 20, and 24 ]
    DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Participants achieved a clinically meaningful improvement in DAS28 if there was a reduction of at least 1.2 units from baseline.
  • Time to DAS28 Response by DAS28 Category [ Time Frame: Weeks 4, 8, 12, 16, 20, and 24 ]
    Time to response is the number of days from date of first infusion to date of event. DAS28 response was defined as achievement of Low Disease Activity (DAS28 ≥2.6 to ≤3.2), Remission (DAS28 <2.6), or Clinically Meaningful Improvement (change of >1.2 from baseline).
  • Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at Least 0.22 Units [ Time Frame: Weeks 4, 8, 12, 16, 20, and 24 ]
    HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.
  • Percentage of Participants With Improvement in Physical Function by HAQ-DI Category [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ]
    Physical function scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. The HAQ-DI score at every visit was categorized into none to mild disability (HAQ-DI <1), moderate disability (1≤ HAQ-DI <2) and severe disability (HAQ-DI ≥2). The percentages of the participants falling in each of these categories with respect to the visits were determined.
  • HAQ-DI Score by Visit [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24 ]
    HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3..
  • C-Reactive Protein (CRP) Values by Study Visit [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24 ]
    CRP is an acute phase inflammatory marker. The serum concentration of CRP is measured in milligrams per liter (mg/L). A reduction in the level is considered an improvement.
  • Erythrocyte Sedimentation Rate [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24 ]
    ESR (measured in mm/hr) is an inflammation marker used to determine acute phase response.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2010)
  • Number and percentage of patients achieving an improvement in DAS28 score (reduction of 1.2 units), low disease activity (DAS28</= 3.2) and those achieving remission (DAS28<2.6) [ Time Frame: Assessments every 4 weeks for 24 weeks ]
  • Time to improvement, low disease activity and/or remission in DAS28 [ Time Frame: Assessments every 4 weeks for 24 weeks ]
  • Change of erythrocyte sedimentation rate and C-reactive protein [ Time Frame: Assessments every 4 weeks for 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
Official Title  ICMJE Multicenter, Open-Label Study to Evaluate the Safety, Tolerability and the Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti- TNF Therapy.
Brief Summary This open-label single-arm study will evaluate the safety, tolerability and efficacy of tocilizumab [RoActemra/Actemra] in patients with moderate to severe rheumatoid arthritis who experience an inadequate clinical response to a stable dose of non-biologic disease modifying anti-rheumatic drugs (DMARD) or anti-tumor necrosis factors (TNFs). RoActemra/Actemra will be administered as a monotherapy or in combination with DMARDs. RoActemra/Actemra will be administered as intravenous infusion at a dose of 8 mg/kg every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg iv infusion, every 4 weeks for a total of 6 infusions
Study Arms  ICMJE Experimental: 1
Intervention: Drug: tocilizumab [RoActemra/Actemra]
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2012)
95
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2010)
100
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients, >/=18 years of age
  • moderate to severe rheumatoid arthritis (DAS28 >3.2) of 6 months duration
  • inadequate clinical response to non-biologic DMARDs or anti-TNF
  • bodyweight </=150 kg

Exclusion Criteria:

  • rheumatic autoimmune disease or inflammatory joint disease other than RA
  • major surgery within 8 weeks prior to screening or planned major surgery within 6 months following screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bahrain,   Iran, Islamic Republic of,   Kuwait,   Qatar,   United Arab Emirates
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01089023
Other Study ID Numbers  ICMJE ML22440
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date June 2014

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