A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01353859
First received: May 13, 2011
Last updated: May 8, 2014
Last verified: May 2014

May 13, 2011
May 8, 2014
March 2011
July 2012   (final data collection date for primary outcome measure)
Percentage of Participants Achieving Low Disease Activity Score [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Disease Activity Score using 28-Joint Count (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/hour]) 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. DAS28 less than or equal to (≤3.2) equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.
Percentage of patients achieving low Disease Activity Score (DAS </=3.2) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01353859 on ClinicalTrials.gov Archive Site
  • Time to Achieve Low Disease Activity (DAS28 ≤3.2) [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]
    DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) 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. DAS28 ≤3.2 = low disease activity; time to low disease activity was calculated as the time in weeks from the date of first infusion to the first achievement of DAS28 ≤3.2
  • Percentage of Participants With a Clinically Significant Improvement in DAS28 Score [ Time Frame: Weeks 4, 8, 12, 16, 20 and 24 ] [ Designated as safety issue: No ]
    DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) 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; a clinically significant improvement in DAS28 score was defined as a reduction of at least 1.2 units.
  • Time to Clinically Significant Improvement in DAS28 [ Time Frame: Weeks 4, 8, 12, 16, 20 and 24 ] [ Designated as safety issue: No ]
    DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) 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; a clinically significant improvement is a reduction in DAS28 score of at least 1.2 units. Time to clinically significant improvement was determined in weeks from the date of first infusion to the date of first achievement of reduction of 1.2 units in DAS28.
  • Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6) [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]
    DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) 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. Remission was defined as DAS28 <2.6.
  • Time to Achieve DAS28 Remission (DAS28 <2.6) [ Time Frame: Weeks 4, 8, 12, 16, 20 and 24 ] [ Designated as safety issue: No ]
    DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) 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. DAS28 remission was defined as DAS28 <2.6. Time to achieve remission was calculated in weeks as the time from the date of first infusion to the date of first achieving remission.
  • Percentage of Participants With DAS28 <3.2 by Visit [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]
    DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) 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. DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
  • Percentage of Participants Achieving American College of Rheumatology (ACR) 20%, 50%, and 70% Improvement (ACR20, ACR50, or ACR70) Response [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    ACR20/50/70 response was defined as ≥20%, ≥50%, or ≥70% improvement, respectively, in swollen/tender joint count (66 joints assessed for swelling and 68 joints assessed for tenderness) as well as improvement in at least 3 of the 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the health assessment questionnaire [HAQ]); and acute phase response: C-reactive protein (CRP) or ESR.
  • Erythrocyte Sedimentation Rate [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]
    Erythrocyte Sedimentation rate was measured in mm/hour and was used to determine the acute phase response. Lower ESR values indicate reduction in disease activity; normal reference range: 0-20 mm/hr.
  • C-Reactive Protein Levels [ Time Frame: Baseline, Weeks 4, 8, 12,16, 20, and 24 ] [ Designated as safety issue: No ]
    CRP levels were measured in milligrams/liter (mg/L) and were used to determine the acute phase response. A reduction in CRP levels is considered an improvement; normal reference range ≤10 mg/L.
  • Safety: Incidence of adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Incidence of patients with adverse event related discontinuation of tocilizumab [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs
An Open Label, Local, Multicenter , Phase IIIb Interventional Study to Assess the Efficacy of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) in Indonesian Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs

This multicenter, open-label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with active rheumatoid arthritis who have an inadequate response to non-biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for a total of 6 infusions plus methotrexate 10-25 mg orally weekly. Anticipated time on study treatment is 24 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 for a total of 6 infusions
  • Drug: methotrexate
    10-25 mg orally weekly
Experimental: Single Arm
Interventions:
  • Drug: tocilizumab [RoActemra/Actemra]
  • Drug: methotrexate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Moderate to severe active rheumatoid arthritis (RA) of >/= 6 months duration
  • Prior treatment with DMARDs for >/= 12 weeks (at stable dose for >/= 8 weeks)
  • Inadequate clinical response to stable dose of non-biologic DMARD (either single or in combination)

Exclusion Criteria:

  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
  • Autoimmune disease other than RA
  • History of or current inflammatory joint disease other than RA
  • Previous treatment with any biologic drug that is used in the treatment of RA
  • Intra-articular or parenteral corticosteroids within 6 weeks prior to baseline
  • Impaired liver, renal or hematologic function
  • Active current or history of recurrent infection
  • History of or currently active primary or secondary immunodeficiency
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Indonesia
 
NCT01353859
ML25536
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2014

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