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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01071798
First received: February 18, 2010
Last updated: January 25, 2016
Last verified: January 2016

February 18, 2010
January 25, 2016
January 2010
October 2014   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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).
Efficacy: DAS28 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01071798 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With a Treatment-Emergent Adverse Event (TEAE) [ Time Frame: during Cycle 1, during Cycle 2, during the trial (within 12 months) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • Safety: drug reactions and infections [ Time Frame: throughout obseration period of 6 months ] [ Designated as safety issue: No ]
  • Impact of various factors (CCP and RF status, previous therapies, age, comorbidities) on efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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An Observational Study on the Safety and Effectiveness of Rituximab in Patients With Severe Active Rheumatoid Arthritis
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).
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Participants starting treatment with rituximab
Rheumatoid Arthritis
Drug: Rituximab
As prescribed by physician
Other Names:
  • Mabthera
  • Rituxan
Main Analysis Set
Participants who received at least one cycle of rituximab
Intervention: Drug: Rituximab
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 Nov-Dec;33(6):887-94. Epub 2015 Oct 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1653
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
United States
 
NCT01071798
ML22639
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP