An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01388309
First received: July 4, 2011
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This observational study will evaluate in clinical practice the change in Diseas e Activity Score (DAS28) in patients with rheumatoid arthritis and an inadequate response to DMARDs who are initiated on treatment with RoActemra/Actemra (tocil izumab). Data will be collected from eligible patients (on 8 mg/kg or 4 mg/kg in travenously every 4 weeks, with or without methotrexate) for 12 months.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: DAS Evaluation of RA Activity in Patients Treated With Tocilizumab

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Disease activity score (DAS28) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DAS 28 (subgroup on monotherapy) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • DAS 28 (subgroup on 4 mg/kg dose) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: July 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with rheumatoid arthritis and an inadequate response to DMARDs who are initiated on treatment with RoActemra/Actemra

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Moderate to severe active rheumatoid arthritis
  • Inadequate response or intolerance to previous therapy with one or more traditional DMARDs

Exclusion Criteria:

  • Pregnant or lactating women
  • Active infection
  • Positive for hepatitis B, hepatitis C or HIV infection
  • Concomitant anti-TNF drugs
  • Contraindications to treatment with RoActemra/Actemra
  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: NCT01388309

Locations
Slovakia
Banska Bystrica, Slovakia, 975 17
Bratislava, Slovakia, 826 06
Kosice, Slovakia, 04011
Piestany, Slovakia, 921 12
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: NCT01388309     History of Changes
Other Study ID Numbers: ML25524
Study First Received: July 4, 2011
Last Updated: October 6, 2014
Health Authority: Slovakia: State Institue for Drug Control

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

ClinicalTrials.gov processed this record on October 23, 2014