Clinical trial NCT01071798: An Observational Study on the Safety and Effectiveness of Rituximab in Patients With Severe Active Rheumatoid Arthritis
Official title: A Prospective, Multi-center, Non-interventional Observational Study to Evaluate the Safety and Effectiveness of MabThera® (Rituximab) Within the First 6 Months (in Case of Re-therapy the First 12 Months) of Treatment in Patients With Severe Active Rheumatoid Arthritis in Routine Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-02-19
Enrollment: 1653
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 starting treatment with rituximab

Brief summary: This prospective observational study aims to evaluate safety, application and onset of effect of rituximab in clinical routine treatment of severe active rheumatoid arthritis during the first 6 months (in case of re-therapy: 12 months).


Eligibility criteria: Inclusion Criteria:

* No pretreatment with rituximab
* Age 18 years or older
* Patients with active, severe rheumatoid arthritis with prescription of rituximab according to German Summary of Product Characteristics (SmPC - "Fachinformation")
* Patients with signed informed consent
* Female patients with secure contraception

Exclusion Criteria:

* Violation of Selection criteria:

  1. Active severe infection
  2. Severe heart failure (NYHA class IV) or severe, uncontrollable heart disease
  3. Participation in an interventional study within the last 3 months before therapy start with rituximab
  4. Pretreatment with rituximab
  5. Age \<18 years
  6. Known intolerability of monoclonal antibodies or chimeric monoclonal antibodies
  7. Known pregnancy or breastfeeding
* Data of patients without approval of data by the physician
* Patients without informed consent
* Double documentation

Primary outcomes:
measure: DAS28 Score
timeFrame: at baseline of each cycle and approximately 15 days, 6 weeks (only cycle 1), 12 weeks (3 months), 18 weeks (only cycle 1), and 24 weeks (6 months) after the start of the respective cycle
measure: HAQ Disability Index (HAQ-DI)
timeFrame: at baseline of each cycle and approximately 15 days, 6 weeks (only cycle 1), 12 weeks (3 months), 18 weeks (only cycle 1), and 24 weeks (6 months) after the start of the respective cycle
Secondary outcomes:
measure: Percentage of Participants With a Treatment-Emergent Adverse Event (TEAE)
timeFrame: during Cycle 1, during Cycle 2, during the trial (within 12 months)
measure: Number of Participants Who Received Only One Treatment Cycle With Clinically Relevant Changes in HAQ-Score at Last Visit During Therapy Compared to Baseline (Categorized)
timeFrame: 24 weeks after starting Cycle 1
measure: Number of Participants Who Received Two Cycles With Clinically Relevant Changes in HAQ-Score at Last Visit During Therapy Compared to Baseline (Categorized)
timeFrame: 24 weeks after starting Cycle 2
Other outcomes:
Locations:
city: Berlin
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Tony HP, Roll P, Mei HE, Blumner E, Straka A, Gnuegge L, Dorner T; FIRST/ ReFIRST study teams. Combination of B cell biomarkers as independent predictors of response in patients with rheumatoid arthritis treated with rituximab. Clin Exp Rheumatol. 2015 Nov-Dec;33(6):887-94. Epub 2015 Oct 30.