A Study of Tocilizumab With or Without Methotrexate in Patients With Rheumatoid Arthritis.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01010503
First received: November 9, 2009
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

This open-label, single-arm, non-randomized study will evaluate the adherence and persistence to tocilizumab therapy in patients with moderate to severe active rheumatoid arthritis, who have an inadequate clinical response to non-biologic DMARDs. Patients will receive tocilizumab 8 mg/kg as intravenous infusion once every 4 weeks in combination with methotrexate or in case of intolerance to methotrexate as monotherapy. The anticipated time of study treatment is 6 months. The target sample size is 20-50 patients.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: tocilizumab [RoActemra/Actemra]
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Adherence and Persistence to Tocilizumab in Combination With Methotrexate or Tocilizumab Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis in Local Environment.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants Adherent to Original Treatment [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Adherence rate to original treatment according to the protocol included all participants that received the study drug beginning from Week 8 and remaining until the end of the study. This number represents participants with no changes in treatment protocol, participants with treatment discontinuation, and participants with dose reduction, but not participants that withdrew from the study prematurely.

  • Percentage of Participants Receiving Less Than or Equal to (≤) 1 Dose of Study Drug Who Discontinued Treatment for Any Reason [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]
  • Percentage of Participants Receiving Greater Than (>) 1 Dose Who Discontinued Treatment for Any Reason [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]
  • Percentage of Participants Withdrawing From the Study Prematurely for Any Reason [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Dose Reduction to Tocilizumab 4 mg/kg [ Time Frame: Weeks 0, 4, 8, 12, 16, and 20 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease Activity Score Based on 28-Joint Count (DAS28) [ Time Frame: Weeks 0, 4, 12, and 24 ] [ Designated as safety issue: No ]
    DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) 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 ≤3.2 equals (=) low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.

  • Patient Global Assessment of Pain [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]
    Participants were asked to rate their pain using a 0 to 100 mm visual analog scale (VAS), where 0 mm = no pain and 100 mm = worst possible pain. The participant was asked to mark the line corresponding to their perceived level of pain and the distance in mm from the left edge of the scale was measured.

  • Patient Global Assessment of Disease Activity [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]
    The participant's assessment of disease activity was performed using a 100 mm VAS ranging from no activity (0) to maximal activity (100). The participant was asked to mark the line corresponding to their perceived level of disease activity and the distance in mm from the left edge of the scale was measured.

  • Physician's Global Assessment of Disease Activity [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]
    Physician's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100). The physician was asked to mark the line corresponding to their perceived level of the participant's disease activity and the distance in mm from the left edge of the scale was measured.

  • Swollen Joint Count (SJC) [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]
    The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not swollen or 1=swollen. The total number was calculated from all the joints for a maximum score of 28.

  • Tender Joint Count (TJC) [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]
    The following 28 joints were assessed by the physician for tenderness: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not tender or 1=tender. The total number was calculated from all the joints for a maximum score of 28.

  • Erythrocyte Sedimentation Rate (ESR) [ Time Frame: Weeks 0, 4, 12, 20, and 24 ] [ Designated as safety issue: No ]
    ESR indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.

  • C-Reactive Protein (CRP) [ Time Frame: Weeks 0, 4, 12, 20, and 24 ] [ Designated as safety issue: No ]
    CRP is an acute phase protein. Levels of CRP increase with inflammation.

  • Health Assessment Questionnaire - Disability Index (HAQ-DI) Score [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: No ]
    The HAQ-DI was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from 4 response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.

  • Short Form-36 (SF-36) [ Time Frame: Weeks 0, 12, and 24 ] [ Designated as safety issue: No ]
    The SF-36 measures the impact of disease on overall quality of life and consists of 8 subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health.


Enrollment: 32
Study Start Date: June 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: tocilizumab [RoActemra/Actemra]
tocilizumab 8 mg/kg intravenous infusion once in 4 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
  • moderate to severe active rheumatoid arthritis
  • inadequate response, or intolerance to previous therapy with one or more traditional DMARDs
  • DAS >3.6
  • pneumology examination (including chest x-ray and quantiferon)

Exclusion Criteria:

  • < 18 years of age
  • active infection
  • active tuberculosis
  • uncontrolled hyperlipoproteinaemia
  • demyelinating disorders
  • concomitant anti-TNF drugs
  • history of intestinal ulceration and diverticulitis
  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: NCT01010503

Locations
Slovakia
Piestany, Slovakia, 921 12
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: NCT01010503     History of Changes
Other Study ID Numbers: ML22508, 2009-011520-53
Study First Received: November 9, 2009
Results First Received: April 8, 2014
Last Updated: July 23, 2014
Health Authority: Slovakia: State Institute for Drug Control

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 02, 2014