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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01613027
First received: May 25, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This observational study will evaluate the effect on disease activity and the sa fety in routine clinical practice of MabThera/Rituxan (rituximab) in patients wi th severe active rheumatoid arthritis, who have an inadequate response to one or more anti-TNF therapies. Data will be collected for 12 months.


Condition
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 ]

Estimated Enrollment: 143
Study Start Date: February 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

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

Criteria

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 ClinicalTrials.gov identifier: NCT01613027

Contacts
Contact: Reference Study ID Number: ML27998 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Greece
Recruiting
Athens, Greece, 11521
Recruiting
Athens, Greece, 14527
Recruiting
Athens, Greece, 11527
Recruiting
Athens, Greece, 15562
Recruiting
Haidari, Greece, 124 62
Recruiting
Herakleion, Greece, 71110
Recruiting
Ioannina, Greece, 455 00
Terminated
Kavala, Greece, 65500
Recruiting
Larissa, Greece, 411 10
Recruiting
Patra, Greece, 26335
Recruiting
Patras, Greece, 265 04
Recruiting
Thessaloniki, Greece, 546 42
Recruiting
Thessaloniki, Greece, 54636
Recruiting
Thessaloniki, Greece, 57010
Recruiting
Thessaloniki, Greece, 544 65
Recruiting
Voula, Greece, 16673
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: NCT01613027     History of Changes
Other Study ID Numbers: ML27998
Study First Received: May 25, 2012
Last Updated: August 4, 2014
Health Authority: Greece: Ministry of Health and Welfare

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014