An Observational Study of MabThera/Rituxan in Patients With Severe Active Rheumatoid Arthritis (Positive Trial)

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: May 25, 2012
Last updated: November 2, 2015
Last verified: November 2015
This observational study will evaluate the effect on disease activity and the safety in routine clinical practice of MabThera/Rituxan (rituximab) in patients with severe active rheumatoid arthritis, who have an inadequate response to one or more anti-TNF therapies. Data will be collected for 12 months.

Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study on the Efficacy and Safety of MabThera (Rituximab) in seroPOSITIVE TNF IR Patients With Severe Active Rheumatoid Arthritis in Routine Clinical Practice (POSITIVE TRIAL)

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean change in disease activity at 6 and 12 months [ Time Frame: From baseline to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with treatment response (Disease activity DAS28 amelioration >/= 1.2) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percentages of patients drop-outs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Impact in Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 135
Study Start Date: January 2012
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)


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 severe active rheumatoid arthritis who have an inadequate response or intolerance to TNF-inhibitors therapy

Inclusion Criteria:

  • Adult patients over 18 years of age
  • Patients with rheumatoid arthritis with inadequate response to one or more anti-TNF therapies
  • No prior use of MabThera/Rituxan (rituximab)

Exclusion Criteria:

  • Active severe infection
  • Severe heart failure or severe uncontrolled disease
  • Pregnancy or breast feeding
  • Receiving an investigational drug in the context of another clinical trial
  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 identifier: NCT01613027

Athens, Greece, 11521
Athens, Greece, 11527
Athens, Greece, 14527
Athens, Greece, 155 62
Haidari, Greece, 124 62
Herakleion, Greece, 71110
Ioannina, Greece, 455 00
Kavala, Greece, 65500
Larissa, Greece, 411 10
Patra, Greece, 26335
Patras, Greece, 265 04
Thessaloniki, Greece, 57010
Thessaloniki, Greece, 546 42
Thessaloniki, Greece, 54636
Thessaloniki, Greece, 544 65
Voula, Greece, 16673
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01613027     History of Changes
Other Study ID Numbers: ML27998
Study First Received: May 25, 2012
Last Updated: November 2, 2015
Health Authority: Greece: Ministry of Health and Welfare

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on November 25, 2015