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An Observational Study on Patients With Rheumatoid Arthritis Treated With MabThera (Rituximab)

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ClinicalTrials.gov Identifier: NCT01075477
Recruitment Status : Completed
First Posted : February 25, 2010
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This observational study will assess the execution, efficacy and safety of treatment with MabThera in patients with rheumatoid arthritis. Data from patients receiving MabThera according to local treatment guidelines will be collected for 29 months. Target sample size is 100-200 patients.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: rituximab [Mabthera/Rituxan]

Study Type : Observational
Actual Enrollment : 151 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Naturalistic Prospective Non-interventional Study on Rheumatoid Arthritis (RA) Patients Treated With Rituximab According to Local Treatment Guidelines
Study Start Date : September 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab
U.S. FDA Resources

Group/Cohort Intervention/treatment
Cohort Drug: rituximab [Mabthera/Rituxan]
As prescribed by physician



Primary Outcome Measures :
  1. Efficacy: DAS28 [ Time Frame: 29 months ]

Secondary Outcome Measures :
  1. Efficacy: TJC, SJC, ESR, HAQ, CRP, patient's assessment (VAS) [ Time Frame: 29 months ]
  2. Safety: serious and non-serious adverse events [ Time Frame: 29 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with rheumatoid arthritis on or commencing treatment with rituximab [MabThera]
Criteria

Inclusion Criteria:

  • adult patients, >/= 18 years of age
  • rheumatoid arthritis
  • treatment with rituximab

Exclusion Criteria:

  • unable/unwilling to give informed consent to data collection

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): NCT01075477


Locations
Finland
Helsinki, Finland, 00290
Hämeenlinna, Finland, 13530
Joensuu, Finland, 80210
Jyvaeskylae, Finland, 40620
Paimio, Finland, 21540
Riihimäki, Finland, 11101
Seinäjoki, Finland, 60220
Tampere, Finland, 33520
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01075477     History of Changes
Other Study ID Numbers: ML22609
First Posted: February 25, 2010    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
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents