A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic and/or Biologic DMARDS

This study has been completed.
Sponsor:
Collaborator:
Clalit Health Services
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01149057
First received: June 22, 2010
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

This single arm, open-label study will evaluate the efficacy and safety of RoAct emra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to non-biologic and/or biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive intravenous RoActemra/Actemra at a dose of 8 mg/kg every 4 weeks. Anticipated time on study treatment is 96 weeks.


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

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 Efficacy and Safety Of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARDs and/or Biologic DMARDs

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue score [ Time Frame: from baseline to week 24, week 48, week 72 and week 96 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in bone mineral density (BMD) in lumbar spine region, assessed by Dual Energy X-ray Absorptiometry (DXA test) [ Time Frame: from baseline to week 96 ] [ Designated as safety issue: No ]
  • Changes in BMD in total hip and neck region, assessed by DXA test [ Time Frame: from baseline to week 96 ] [ Designated as safety issue: No ]
  • Number and percentage of patients achieving remission, defined as disease activity score DAS28<2.6 [ Time Frame: week 24, week 48, week 72 and week 96 ] [ Designated as safety issue: No ]
  • Response according to American College of Rheumatology score (ACR20/ACR50/ACR70) [ Time Frame: week 24, week 48, week 72 and week 96 ] [ Designated as safety issue: No ]
  • Change in hemoglobin level [ Time Frame: from baseline to week 24, 48, 72 and 96 ] [ Designated as safety issue: No ]
  • Change according to Health Assessment Questionnaire (HAQ) [ Time Frame: from baseline to week 96 ] [ Designated as safety issue: No ]
  • Safety: Adverse events [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Enrollment: 145
Study Start Date: October 2010
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg intravenously, every 4 weeks for 96 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
  • Active moderate to severe rheumatoid arthritis
  • Inadequate response to >/=3 DMARDs (non-biologic and/or biologic)
  • Current treatment at stable dose for >/=8 weeks
  • Etanercept discontinued >/=2 weeks, Anakinra >/=1 week, Infliximab, Adalimumab, Abatacept, Golimumab, Certolizumab >/=4 weeks, prior to baseline visit. Patients have discontinued MabThera/Rituxan or Ocrelizumab >/=16 weeks, and must have proven B-cell repletion

Exclusion Criteria:

  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline
  • Rheumatic autoimmune disease other than RA
  • Functional class IV (American College of Rheumatology Classification)
  • Prior history or current inflammatory joint disease other than RA
  • Oral corticosteroids at a dose of >10 mg/day prednisone equivalent
  • Positive hepatitis B surface antigen (HBsAg) and / or total hepatitis B core antibodies (HBcAb) or hepatitis C virus (HCV) antibody
  • Current or history of recurrent bacterial, viral, fungal or mycobacterial infection
  • History of or currently active primary or secondary immunodeficiency
  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: NCT01149057

Locations
Israel
Afula, Israel, 18101
Ashkelon, Israel, 78306
Beer Sheva, Israel, 8410101
Hadera, Israel, 38100
Haifa, Israel, 34354
Haifa, Israel, 34362
Haifa, Israel, 3339419
Holon, Israel, 58100
Jerusalem, Israel, 91240
Jerusalem, Israel, 9112001
Kfar Saba, Israel, 44281
Petach Tikva, Israel, 4941492
Ramat Gan, Israel, 5262000
Rehovot, Israel, 76100
Rishon Lezion, Israel
Tel Aviv, Israel, 6423906
Sponsors and Collaborators
Hoffmann-La Roche
Clalit Health Services
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01149057     History of Changes
Other Study ID Numbers: ML22873
Study First Received: June 22, 2010
Last Updated: September 10, 2014
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on September 16, 2014