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A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy in Patients With Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01251120
First received: November 30, 2010
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This randomized, open-label, parallel-group study will assess the effect on disease remission of RoActemra/Actemra (tocilizumab) in combination with disease-modifying antirheumatic drugs (DMARDs) versus current best practice non-biologic DMARD therapy in patients with moderate-to-severe active rheumatoid arthritis. Patients who are randomly assigned to the RoActemra/Actemra treatment group will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on study treatment is 12 months.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pragmatic, Randomized, Parallel Group Study of the Effect on Disease Remission, Work Productivity and Tolerability of Tocilizumab in Combination With DMARDs and Individually Designed Best Practice DMARD Therapy in Patients With Early, Moderate to Severe Rheumatoid Arthritis

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:
  • Proportion of patients achieving disease remission (DAS28 <2.6) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Work Productivity (absence from work) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Proportion of patients achieving disease remission (DAS28<2.6) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Proportion of patients achieving responses according to American College of Rheumatology (ACR) criteria [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Proportion of patients achieving clinical disease activity index (CDAI) remission [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety (incidence of adverse events) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: November 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg intravenously every 4 weeks plus background DMARDs (including methotrexate)
Active Comparator: 2 Drug: DMARD
Non-biologic DMARDs (including methotrexate) according to current best practice

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, over the age of 18 years
  • Diagnosis of moderate-to-severe active early rheumatoid arthritis (RA) of less than 2 years duration
  • DAS28 >3.2
  • Swollen joint count (SJC) >/=6 (66 joint count), and tender joint count (TJC) >/=6 (68 joint count)
  • Patients who have received DMARDs (including methotrexate) for 3-7 months

Exclusion Criteria:

  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
  • Rheumatic autoimmune disease other than rheumatoid arthritis (secondary Sjögrens syndrome or nodulosis with RA is permitted)
  • Functional class III or IV as defined by ACR Classification of Functional Status in Rheumatoid Arthritis
  • Prior history of or current inflammatory joint disease other than RA
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01251120

Locations
Finland
Helsinki, Finland, 00029
Hämeenlinna, Finland, 13530
Jyväskylä, Finland, 40620
Kuopio, Finland, 70101
Riihimäki, Finland, 11101
Rovaniemi, Finland, 96101
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: NCT01251120     History of Changes
Other Study ID Numbers: ML25346
Study First Received: November 30, 2010
Last Updated: May 7, 2013
Health Authority: Finland: Finnish Medicines Agency

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 21, 2013