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An Observational Study on The Safety and Effectiveness of Mabthera (Rituximab) in The First Six Months of Treatment in Patients With Severe Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01071798
First received: February 18, 2010
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

This prospective observational study will evaluate the safety and effectiveness of Mabthera (Rituximab) within the first 6 months of treatment in patients with severe active rheumatoid arthritis in routine care. For each eligible patient da ta will be collected for 6 months. Target sample size is <2000 patients.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multi-center Non-interventional Observational Study to Evaluate the Safety and Effectiveness of MabThera® (Rituximab) Within the First 6 Months of Treatment in Patients With Severe Active Rheumatoid Arthritis in Routine Care.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Efficacy: disease activity (DAS28) and functional capacity (HAQ) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: adverse drug reactions and infections [ Time Frame: throughout obseration period of 6 months ] [ Designated as safety issue: No ]
  • Impact of various factors (CCP and RF status, previous therapies, age, comorbidities) on efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 1633
Study Start Date: January 2010
Study Completion Date: September 2014
Primary Completion Date: September 2014 (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 starting treatment with rituximab

Criteria

Inclusion Criteria:

  • adult patients, >/= 18 years of age
  • severe active rheumatoid arthritis; eligible for treatment with rituximab according to current SPC
  • informed consent to data collection
  • ongoing contraception (for female patients only)

Exclusion Criteria:

  • previous treatment with rituximab (Mabthera)
  • allergy against monoclonal antibodies, respectively chimeric monoclonal antibodies
  • active severe infection
  • severe heart failure (NYHA Class IV) or severe, uncontrolled cardiac disease
  • treatment in other studies within 3 months before rituximab therapy
  • pregnancy or breast feeding
  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: NCT01071798

Locations
Germany
Berlin, Germany, 13125
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: NCT01071798     History of Changes
Other Study ID Numbers: ML22639
Study First Received: February 18, 2010
Last Updated: November 3, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

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

ClinicalTrials.gov processed this record on November 27, 2014