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

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ClinicalTrials.gov Identifier: NCT01388309
Recruitment Status : Completed
First Posted : July 6, 2011
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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

Condition or disease
Rheumatoid Arthritis

Study Type : Observational
Actual Enrollment : 64 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DAS Evaluation of RA Activity in Patients Treated With Tocilizumab
Study Start Date : July 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Group/Cohort
Cohort



Primary Outcome Measures :
  1. Disease activity score (DAS28) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. DAS 28 (subgroup on monotherapy) [ Time Frame: 12 months ]
  2. DAS 28 (subgroup on 4 mg/kg dose) [ Time Frame: 12 months ]
  3. Safety: Incidence of adverse events [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01388309     History of Changes
Other Study ID Numbers: ML25524
First Posted: July 6, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

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