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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01075477
First received: February 24, 2010
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Rheumatoid Arthritis
 Drug: rituximab [Mabthera/Rituxan]

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Efficacy: DAS28 [ Time Frame: 29 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: TJC, SJC, ESR, HAQ, CRP, patient's assessment (VAS) [ Time Frame: 29 months ] [ Designated as safety issue: No ]
  • Safety: serious and non-serious adverse events [ Time Frame: 29 months ] [ Designated as safety issue: No ]

Enrollment: 151
Study Start Date: September 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort Drug: rituximab [Mabthera/Rituxan]
As prescribed by physician

  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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01075477     History of Changes
Other Study ID Numbers: ML22609
Study First Received: February 24, 2010
Last Updated: May 23, 2013
Health Authority: Finland: Ministry of Social Affairs and Health

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013