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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01071798
First received: February 18, 2010
Last updated: August 4, 2014
Last verified: August 2014

February 18, 2010
August 4, 2014
January 2010
August 2014   (final data collection date for primary outcome measure)
Efficacy: disease activity (DAS28) and functional capacity (HAQ) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Efficacy: DAS28 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01071798 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Safety: 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 ]
Not Provided
Not Provided
 
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
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.

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients starting treatment with rituximab

Rheumatoid Arthritis
Drug: rituximab [Mabthera/Rituxan]
As prescribed by physician
Cohort
Intervention: Drug: rituximab [Mabthera/Rituxan]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1633
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01071798
ML22639
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP