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

Rheumatoid Arthritis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613027
• Other study ID #: ML27998
• Status: Completed
• Phase: N/A
• First received: May 25, 2012
• Last updated: July 1, 2016
• Start date: February 2012
• Est. completion date: September 2015

Study information

• Verified date: July 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in disease activity at 6 and 12 months		From baseline to 12 months	No
Secondary	Percentage of patients with treatment response (Disease activity DAS28 amelioration >/= 1.2)		12 months	No
Secondary	Percentages of patients drop-outs		12 months	No
Secondary	Impact in Quality of Life		12 months	No
Secondary	Safety: incidence of adverse events		12 months	No