A Study to Assess the Effect of Tocilizumab on Signs and Symptoms in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00848120
First received: February 19, 2009
Last updated: December 23, 2014
Last verified: December 2014
  Purpose

This single arm, open label study will assess the safety and efficacy, with regard to reduction of signs and symptoms,of treatment with tocilizumab in patients with moderate to severe active rheumatoid arthritis. Patients will receive tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions. Patients already receiving methotrexate at entry into the study may continue with their treatment together with tocilizumab.The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.


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: An Open Label Study to Evaluate the Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20 Response) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    ACR20 response: greater than or equal to (≥) 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (visual analog scale [VAS]), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) erythrocyte sedimentation rate (ESR) at each visit.


Secondary Outcome Measures:
  • Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (VAS), 4) participant assessment of functional disability via a HAQ, and 5) ESR at each visit.

  • Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    ACR70 response: ≥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (VAS), 4) participant assessment of functional disability via a HAQ, and 5) ESR at each visit.

  • HAQ Disability Index (HAQ-DI) Score at Baseline and Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    HAQ-DI is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To calculate HAQ-DI the participant must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst).

  • Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Baseline and Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participants response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the health status.

  • Disease Activity Score Based on 28 Joint Count - Erythrocyte Sedimentation Rate (DAS28-ESR) at Baseline and Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    DAS28-ESR calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (millimeters per hour [mm/hour]) and Patient's Global Assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to 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 Participants With Disease Remission at Week 24 Assessed Using DAS28-ESR [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    DAS28-ESR calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hour) and Patient's Global Assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 <2.6=remission.

  • Percentage of Participants With Low Disease Activity at Week 24 Assessed Using DAS28-ESR [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    DAS28-ESR calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hour) and Patient's Global Assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 >2.6 and <3.2=low disease activity.

  • Time to Onset of ACR20/50/70 Response [ Time Frame: Weeks 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]
    Time to onset of ACR 20/50/70 response was calculated as the number of weeks from the administration of the first dose of study drug until the date of first achievement of ACR 20/50/70 per criteria.


Enrollment: 29
Study Start Date: December 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks for 24 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;
  • rheumatoid arthritis diagnosed >8 weeks and <4 years prior to baseline;
  • naive to, or not responding well to, methotrexate;
  • swollen joint count >=8 (66 joint count) and tender joint count>=8 (68 joint count) at screening and baseline.

Exclusion Criteria:

  • rheumatic autoimmune disease other than rheumatoid arthritis;
  • patients with functional class IV rheumatoid arthritis;
  • history of, or current, inflammatory joint disease other than rheumatoid arthritis, or other systemic autoimmune disorder.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848120

Locations
Philippines
Manila, Philippines, 1003
Manila, Philippines, 1000
Muntinlupa, Philippines, 1770
San Fernando, Philippines, 2000
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: NCT00848120     History of Changes
Other Study ID Numbers: ML22074
Study First Received: February 19, 2009
Results First Received: May 5, 2014
Last Updated: December 23, 2014
Health Authority: Philippines: Department of Health

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Signs and Symptoms
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 25, 2015