Clinical trial NCT01613027: An Observational Study of MabThera in Participants With Severe Active Rheumatoid Arthritis
Official title: A Multicenter Observational Study of the Response to Rituximab (MabThera®) in Seropositive Patients With Rheumatoid Arthritis With Inadequate Response or Intolerance to Treatment With One or More Tumor Necrosis Factor Inhibitors (TNFi)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-06-06
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with severe active, seropositive rheumatoid arthritis who have an inadequate response or intolerance to anti-TNF therapy

Brief summary: This observational study will evaluate the effect on disease activity and the safety in routine clinical practice of MabThera (rituximab) in participants with active seropositive rheumatoid arthritis, who have an inadequate response to one or more tumour necrosis factor inhibitor (anti-TNF) therapies.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years with rheumatoid arthritis (RA)
* Seropositive participants with RA (positive for rheumatoid factor (RF) and/or anti-Citrullinated Cyclic Peptide \[CCP\])
* Active disease despite receiving one or more TNF inhibitors
* Absence of serious or active infection

Exclusion Criteria:

* Participants with serious history of heart failure (class New York Heart Association \[NYHA\] IV) or severe uncontrolled heart disease
* Participants pregnant or lactating
* Prior treatment with Mabthera®
* Participants receiving any other investigational product in the context of other clinical study
* Participants with known hypersensitivity to rituximab or to any of the excipients

Primary outcomes:
measure: Change From Baseline in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Month 6 and Month 12
timeFrame: Baseline, Month 6, Month 12
Secondary outcomes:
measure: Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6 and Month 12
timeFrame: Baseline, Month 6, Month 12
measure: Change From Baseline in Swollen Joint Count (SJC) at Month 6 and Month 12
timeFrame: Baseline, Month 6, Month 12
measure: Change From Baseline in Tender Joint Count (TJC) at Month 6 and Month 12
timeFrame: Baseline, Month 6, Month 12
measure: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and Month 12
timeFrame: Baseline, Month 6, Month 12
measure: Change From Baseline in C-reactive Protein (CRP) at Month 6 and Month 12
timeFrame: Baseline, Month 6, Month 12
measure: Percentage of Participants Who Remained on Treatment or Discontinued Treatment by Month 6 and Month 12
timeFrame: Up to 12 months
measure: Reasons for Discontinuation of Treatment by Month 6
timeFrame: Baseline to Month 6
measure: Reasons for Discontinuation of Treatment by Month 12
timeFrame: Baseline to Month 12
measure: Percentage of Participants With Clinically Meaningful Improvement From Baseline in Modified Health Assessment Questionnaire (M-HAQ)
timeFrame: Up to 12 months
measure: Percentage of Participants With Adverse Events (AEs) and Adverse Drug Reactions (ADRs)
timeFrame: Up to 12 months
measure: Percentage of Participants With Any Non-Serious AE and Any Serious AE by Intensity
timeFrame: Up to 12 months
measure: Percentage of Non-Serious AEs
timeFrame: Up to 12 months
measure: Percentage of Non-Serious ADRs
timeFrame: Up to 12 months
measure: Percentage of Serious AEs
timeFrame: Up to 12 months
measure: Percentage of Serious ADRs
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Haidari
country: Greece
city: Herakleion
country: Greece
city: Ioannina
country: Greece
city: Larissa
country: Greece
city: Patras
country: Greece
city: Patra
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Voula
country: Greece
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: