A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01119859
First received: April 1, 2010
Last updated: January 10, 2013
Last verified: January 2013

April 1, 2010
January 10, 2013
May 2010
January 2012   (final data collection date for primary outcome measure)
Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28) [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement. The analysis was adjusted for stratification factors of duration of RA (≤ 2 years and > 2 years) and region (US and non-US).
Change in disease activity score, DAS28, at Week 24 [ Time Frame: From baseline to Week 24 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01119859 on ClinicalTrials.gov Archive Site
  • Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The percentage of patients who achieved remission of their rheumatic arthritis at Week 24, as measured by a DAS28 score < 2.6, is reported.
  • Percentage of Patients With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    The percentage of patients who had low rheumatic arthritis disease activity at Week 24, as measured by a DAS28 score of 3.2 or less, is reported.
  • Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line "no disease activity" [symptom-free and no arthritis symptoms] and the extreme right end "maximum disease activity"; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line "no pain" and the extreme right end "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.
  • Percentage of Patients With a European League Against Rheumatism (EULAR) Good Response at Week 24 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.
  • Percentage of Patients With a European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.
  • Proportion of patients with an American College of Rheumatology (ACR) response at Week 24 [ Time Frame: From baseline to Week 24 ] [ Designated as safety issue: No ]
  • Proportion of patients with a European League Against Rheumatism (EULAR) response at Week 24 [ Time Frame: From baseline to Week 24 ] [ Designated as safety issue: No ]
  • Incidence of adverse events (AEs) [ Time Frame: 24 weeks of treatment and 8 weeks of follow-up ] [ Designated as safety issue: No ]
  • Laboratory parameters (blood samples) [ Time Frame: Assessments every 4 weeks ] [ Designated as safety issue: No ]
  • Quality of Life (QoL) as assessed through the Health Assessment Questionnaire (HAQ), Short Form-36 (SF-36) and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue questionnaire [ Time Frame: Weeks 4, 8, 12, 16, 20 and 24 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis
A Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid Arthritis

This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where continued treatment with methotrexate was considered inappropriate. Patients were randomized to receive either tocilizumab 8 mg/kg intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. Treatment was anticipated to last 24 weeks. With regard to the blind, the study nurse was unblinded due to the nature of the treatment administration, but the investigator and the patient remained blinded.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: Tocilizumab
    The maximum dose was 800 mg for patients weighing more than 100 kg. Tocilizumab was infused into an arm vein over a 1-hour period.
    Other Names:
    • RoActemra
    • Actemra
  • Drug: Adalimumab
  • Drug: Placebo to tocilizumab
  • Drug: Placebo to adalimumab
  • Experimental: Tocilizumab 8 mg/kg
    Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
    Interventions:
    • Drug: Tocilizumab
    • Drug: Placebo to adalimumab
  • Active Comparator: Adalimumab 40 mg
    Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
    Interventions:
    • Drug: Adalimumab
    • Drug: Placebo to tocilizumab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
326
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, ≥ 18 years of age.
  • Rheumatoid arthritis of > 6 months duration.
  • Intolerant of methotrexate or continued treatment with methotrexate is considered inappropriate.
  • All disease-modifying anti-rheumatic drugs (DMARD) are to be withdrawn prior to receiving study drug.
  • Weight ≤ 150 kg.

Exclusion Criteria:

  • Major surgery (including joint surgery) within 12 weeks prior to baseline or planned major surgery within 6 months after baseline.
  • History of or current inflammatory joint disease other than rheumatoid arthritis (RA).
  • Treatment with a biologic agent at any time prior to baseline.
  • Intra-articular or parenteral corticosteroids ≤ 4 weeks prior to baseline.
  • Active current infection or history of recurrent bacterial, viral, fungal or mycobacterial infection.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Brazil,   Czech Republic,   Finland,   Germany,   Greece,   Mexico,   Portugal,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom
 
NCT01119859
WA19924, 2009-015845-21
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
January 2013

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