A Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01245439
First received: November 17, 2010
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This open-label study will evaluate the safety, tolerability and efficacy of RoA ctemra/Actemra (tocilizumab) in patients with moderate to severe active rheumato id arthritis (RA) on background non-biologic DMARDs who have an inadequate respo nse to current non-biologic DMARDs. Patients will receive 8 mg/kg RoActemra/Acte mra as an intravenous infusion every 24 weeks for a total of 6 infusions. The an ticipated time on study treatment is 24 weeks.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: tocilizumab [RoActemra/Actemra]
Phase 3

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: Local Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety (incidence of adverse events) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number and percentage of patients with AE- and SAE-related discontinuation at every visit [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Number and percentage of patients with all-cause discontinuation at every visit [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse events, serious adverse events and discontinuation in current and prior users of tumor necrosis factor antagonists at every visit [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Number and percentage of patients with elevated liver enzymes at every visit [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Number and percentage of patients with elevations in lipids according to the ATP III guidelines at every visit [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Number and percentage of patients achieving a clinically meaningful improvement in Disease Activity Score 28 (DAS28) at every visit and time to clinically meaningful improvement in DAS28 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Number and percentage of patients achieving low disease activity (DAS28<3.2) at every visit and time to low disease activity [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Number and percentage of patients achieving remission (DAS2.8 <2.6) at every visit and time to DAS28 remission [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Disease activity as measured by DAS28 at every visit [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Number and percentage of patients achieving American College of Rheumatology (ACR) criteria response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: September 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg intravenous 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 active rheumatoid arthritis (DAS28>/=3.2) of >/=6 months duration
  • Body weight </=150 kg
  • Patients are on one or more non-biologic DMARDs at a stable dose for a period >/=8 weeks prior to study treatment
  • Patients with inadequate clinical response to a stable dose of non-biologic DMARD

Exclusion Criteria:

  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
  • Rheumatic autoimmune disease other than rheumatoid arthritis, including systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to rheumatoid arthritis
  • History of or current inflammatory joint disease other than rheumatoid arthritis
  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: NCT01245439

Locations
Turkey
Adana, Turkey, 01330
Ankara, Turkey, 06100
Ankara, Turkey, 06500
Aydin, Turkey, 09100
Bursa, Turkey, 16059
Denizli, Turkey, 20020
Elazi?, Turkey, 23119
Gaziantep, Turkey, 27310
Isparta, Turkey, 32260
Istanbul, Turkey, 34000
Izmir, Turkey, 35100
Izmir, Turkey, 54100
Izmir, Turkey, 35170
Izmit, Turkey, 41380
Konya, Turkey, 42080
Manisa, Turkey, 45200
Samsun, Turkey, 55139
Sivas, Turkey, 58140
Trabzon, Turkey, 61080
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: NCT01245439     History of Changes
Other Study ID Numbers: ML25095
Study First Received: November 17, 2010
Last Updated: July 7, 2014
Health Authority: Turkey: 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 August 01, 2014