An Observational Study on the Safety and Effectiveness of Rituximab in Patients With Severe Active Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01071798
• Other study ID #: ML22639
• Status: Completed
• Phase: N/A
• First received: February 18, 2010
• Last updated: January 25, 2016
• Start date: January 2010
• Est. completion date: October 2014

Study information

• Verified date: January 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1653
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Rituximab
As prescribed by physician

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Tony HP, Roll P, Mei HE, Blümner E, Straka A, Gnuegge L, Dörner 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 No — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DAS28 Score	The DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and the Patient's Global Assessment of Disease Activity (participant-rated rheumatoid arthritis [RA] activity assessment) with transformed scores ranging 0 to 10; higher scores indicate greater affectation due to disease activity.	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	No
Primary	HAQ Disability Index (HAQ-DI)	The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific subcategory items. The standard disability score is calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).	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	No
Secondary	Percentage of Participants With a Treatment-Emergent Adverse Event (TEAE)		during Cycle 1, during Cycle 2, during the trial (within 12 months)	No
Secondary	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)	In the Main Analysis Set participants with only one treatment cycle, the HAQ score was categorized for 12 subgroups as Clinically relevant improvement of HAQ-Score =0.3, Other or no clinical relevant change of HAQ Score, or Clinically relevant worsening of HAQ Score =0.3. Subgroups are defined as Anti-Cyclic citrullinated peptide (CCP) and Rheumatoid factor (RF) negative (-), positive (+), or Non-specified (n.sp.) and Seropositive Non-specified (n.sp.), Seronegative, or Seropositive.	24 weeks after starting Cycle 1	No
Secondary	Number of Participants Who Received Two Cycles With Clinically Relevant Changes in HAQ-Score at Last Visit During Therapy Compared to Baseline (Categorized)	In the Subpopulation With Two Cycles, the HAQ score was categorized for 12 subgroups as Clinically relevant improvement of HAQ-Score =0.3, Other or no clinical relevant change of HAQ Score, or Clinically relevant worsening of HAQ Score =0.3. Subgroups are defined as Anti-Cyclic citrullinated peptide (CCP) and Rheumatoid factor (RF) negative (-), positive (+), or Non-specified (n.sp.) and Seropositive Non-specified (n.sp.), Seronegative, or Seropositive.	24 weeks after starting Cycle 2	No