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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

March 8, 2010
September 19, 2012
January 2010
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT01089023 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
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.

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg iv infusion, every 4 weeks for a total of 6 infusions
Experimental: 1
Intervention: Drug: tocilizumab [RoActemra/Actemra]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
95
May 2012
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Bahrain,   Iran, Islamic Republic of,   Kuwait,   Qatar,   United Arab Emirates
 
NCT01089023
ML22440
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2012

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