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

January 25, 2016 updated by: Hoffmann-La Roche

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1653

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants starting treatment with rituximab

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Main Analysis Set
Participants who received at least one cycle of rituximab
Drug: Rituximab
As prescribed by physician
Other Names:
  • Rituxan
  • Mabthera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DAS28 Score
Time Frame: 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
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
HAQ Disability Index (HAQ-DI)
Time Frame: 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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a Treatment-Emergent Adverse Event (TEAE)
Time Frame: during Cycle 1, during Cycle 2, during the trial (within 12 months)
during Cycle 1, during Cycle 2, during the trial (within 12 months)
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)
Time Frame: 24 weeks after starting Cycle 1
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
Number of Participants Who Received Two Cycles With Clinically Relevant Changes in HAQ-Score at Last Visit During Therapy Compared to Baseline (Categorized)
Time Frame: 24 weeks after starting Cycle 2
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

February 18, 2010

First Submitted That Met QC Criteria

February 18, 2010

First Posted (Estimate)

February 19, 2010

Study Record Updates

Last Update Posted (Estimate)

February 22, 2016

Last Update Submitted That Met QC Criteria

January 25, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML22639

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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