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NCT Number: NCT01071798

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

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).

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Berlin, 13125, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

Drug

As prescribed by physician

Other names: Mabthera, Rituxan

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. Percentage of Participants With a Treatment-Emergent Adverse Event (TEAE)

    Time frame: during Cycle 1, during Cycle 2, during the trial (within 12 months)

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Feb 19, 2010
Registry last updated
Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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