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A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01617005
First received: June 8, 2012
Last updated: October 7, 2016
Last verified: October 2016
  Purpose
This observational study will evaluate the safety and efficacy of tocilizumab in participants with active moderate to severe RA and an inadequate response to non-biologic DMARDs. Data will be collected from each eligible participant initiating tocilizumab treatment over 6 months.

Condition Intervention
Rheumatoid Arthritis
Drug: Tocilizumab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis 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:
  • Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Baseline up to Week 24 ] [ Designated as safety issue: No ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs include both SAEs as well as non-serious AEs.


Secondary Outcome Measures:
  • Number of Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    EULAR response was based on 28-joint disease activity score (DAS28). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline (CFB) in DAS28 score and the level of disease activity reached (absolute DAS28 score). Good responders had a CFB greater than (>) 1.2 with a DAS28 score less than or equal to (<=) 3.2; moderate responders had a CFB >1.2 with a DAS28 score >3.2 to <= 5.1 or a change from baseline >0.6 to <= 1.2 with a DAS28 score <= 5.1; non-responders had a CFB <=0.6 or CFB >0.6 to <=1.2 with DAS28 >5.1. Number of participants who achieved EULAR good response and EULAR moderate response were reported.

  • Number of Participants Who Discontinued Treatment Due to Lack of Efficacy [ Time Frame: Baseline up to Week 24 ] [ Designated as safety issue: No ]
  • Time to Discontinuation Due to Lack of Efficacy [ Time Frame: Baseline up to Week 24 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: May 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Tocilizumab in Moderate to Severe Active RA
Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official Summary of Product Characteristics (SPC), will be observed. The choice of therapy will be based exclusively on the medical decision of the treating physician before study enrollment. The study protocol does not enforce treatment initiation and also does not specify any treatment regimen.
Drug: Tocilizumab
Participants will receive tocilizumab treatment according to effective official SPC. The study protocol does not enforce treatment initiation and also does not specify any treatment regimen.
Other Names:
  • RoActemra
  • L04AC07

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with RA and an inadequate response to non-biologic DMARDs.
Criteria

Inclusion Criteria:

  • Moderate to severe active RA (European League Against Rheumatism [EULAR] criteria)
  • Inadequate response to DMARDs or tumor necrosis factor (TNF) antagonists
  • Initiating treatment with tocilizumab according to SPC

Exclusion Criteria:

  • Rheumatic autoimmune disease other than RA
  • Prior history or current inflammatory joint disease other than RA
  • Previous treatment with any biological drug used in the treatment of RA
  • Previous treatment with tocilizumab
  • Any contraindication to treatment with tocilizumab
  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
  • Pregnant women or nursing (breastfeeding) mothers
  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: NCT01617005

Locations
Montenegro
Podgorica, Montenegro, 81000
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01617005     History of Changes
Other Study ID Numbers: ML25699 
Study First Received: June 8, 2012
Results First Received: October 7, 2016
Last Updated: October 7, 2016
Health Authority: Montenegro: Agency for Drugs and Medical Devices - CALIMS

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

ClinicalTrials.gov processed this record on December 02, 2016