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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01071798 |
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Date of registration:
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18/02/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An Observational Study on the Safety and Effectiveness of Rituximab in Patients With Severe Active Rheumatoid Arthritis
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Scientific title:
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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 |
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Date of first enrolment:
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January 2010 |
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Target sample size:
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1653 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01071798 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Germany
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United States
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Rituximab
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Primary Outcome(s)
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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]
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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]
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Secondary Outcome(s)
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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]
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Percentage of Participants With a Treatment-Emergent Adverse Event (TEAE)
[Time Frame: during Cycle 1, during Cycle 2, during the trial (within 12 months)]
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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