A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00502996
First received: July 17, 2007
Last updated: April 7, 2014
Last verified: April 2014

July 17, 2007
April 7, 2014
February 2006
April 2010   (final data collection date for primary outcome measure)
Adverse event incidence and profile [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Adverse event frequency, rate and profile.
Complete list of historical versions of study NCT00502996 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.
An Expanded Access Program to Assess the Safety of MabThera in Patients With Rheumatoid Arthritis

This single arm study will assess the safety of MabThera plus methotrexate in patients with rheumatoid arthritis who have had a lack of response to 1-5 DMARDs or biological agents. Patients will receive MabThera (1g i.v.) on days 1 and 15, concomitantly with methotrexate >=15mg p.o./week. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: rituximab [MabThera/Rituxan]
    1g iv on days 1 and 15
  • Drug: Methotrexate
    >=15 mg po/week
Experimental: 1
Interventions:
  • Drug: rituximab [MabThera/Rituxan]
  • Drug: Methotrexate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
235
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • rheumatoid arthritis >=6 months;
  • lack of response to 1-5 DMARDs or biological agents;
  • rheumatoid factor positive.

Exclusion Criteria:

  • other chronic inflammatory articular disease or systemic rheumatic disease;
  • joint or bone surgery during 8 weeks prior to randomization;
  • previous treatment with any cell-depleting therapy.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Chile,   Colombia,   Ecuador,   El Salvador,   Mexico,   Peru,   Uruguay,   Venezuela
 
NCT00502996
ML19385
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

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