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A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01089023
First received: March 8, 2010
Last updated: September 19, 2012
Last verified: September 2012
History of Changes
  Purpose

This open-label single-arm study will evaluate the safety, tolerability and efficacy of tocilizumab [RoActemra/Actemra] in patients with moderate to severe rheumatoid arthritis who experience an inadequate clinical response to a stable dose of non-biologic disease modifying anti-rheumatic drugs (DMARD) or anti-tumor necrosis factors (TNFs). RoActemra/Actemra will be administered as a monotherapy or in combination with DMARDs. RoActemra/Actemra will be administered as intravenous infusion at a dose of 8 mg/kg every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.


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: Multicenter, Open-Label Study to Evaluate the Safety, Tolerability and the Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti- TNF Therapy.

Resource links provided by NLM:

Drug Information available for: Tocilizumab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety and Tolerability: AEs, laboratory parameters [ Time Frame: AEs: event-driven assessments throughout study, laboratory assessments every 4 weeks for 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number and percentage of patients achieving an improvement in DAS28 score (reduction of 1.2 units), low disease activity (DAS28</= 3.2) and those achieving remission (DAS28<2.6) [ Time Frame: Assessments every 4 weeks for 24 weeks ] [ Designated as safety issue: No ]
  • Time to improvement, low disease activity and/or remission in DAS28 [ Time Frame: Assessments every 4 weeks for 24 weeks ] [ Designated as safety issue: No ]
  • Change of erythrocyte sedimentation rate and C-reactive protein [ Time Frame: Assessments every 4 weeks for 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 95
Study Start Date: January 2010
Study Completion Date: May 2012
Arms Assigned Interventions
Experimental: 1 Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg iv infusion, every 4 weeks for a total of 6 infusions

  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 rheumatoid arthritis (DAS28 >3.2) of 6 months duration
  • inadequate clinical response to non-biologic DMARDs or anti-TNF
  • bodyweight </=150 kg

Exclusion Criteria:

  • rheumatic autoimmune disease or inflammatory joint disease other than RA
  • major surgery within 8 weeks prior to screening or planned major surgery within 6 months following screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089023

Locations
Bahrain
Manama, Bahrain, 12
Riffa, Bahrain, 28743
Iran, Islamic Republic of
Isfahan, Iran, Islamic Republic of, 8174675731
Tehran, Iran, Islamic Republic of, 1333631151
Tehran, Iran, Islamic Republic of, 14114
Kuwait
Safat, Kuwait, 13041
Qatar
Doha, Qatar, 3050
United Arab Emirates
Abu Dhabi, United Arab Emirates, 51900
Abu Dhabi, United Arab Emirates
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: NCT01089023     History of Changes
Other Study ID Numbers: ML22440
Study First Received: March 8, 2010
Last Updated: September 19, 2012
Health Authority: Qatar: Ministry of Health

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013