Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007394

Trial Description

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Title

An Open-label Study to Evaluate the Safety of MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study will evaluate the efficacy and safety of MabThera in patients with active
rheumatoid arthritis who have had an inadequate response to one prior anti-TNF alpha
inhibitor. MabThera-naive patients will be stratified into 3 arms, according to previous
inadequate response to a)etanercept, b)infliximab or c)adalimumab. Patients will be treated
with MabThera (1g infusion) on day 1 and day 15, and will continue their basic methotrexate
therapy. The anticipated time on study treatment is 2+ years, and the target sample size is
100-500 individuals.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007394
  •   2016/01/27
  •   2014/03/04
  •   no
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Secondary IDs

  •   NCT02079532  (ClinicalTrials.gov)
  •   ML19070  (Hoffmann-La Roche)
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Health Condition or Problem studied

  •   Rheumatoid Arthritis
  •   M05 -  Seropositive rheumatoid arthritis
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Interventions/Observational Groups

  •   Drug: rituximab [MabThera]
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   III
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Primary Outcome

- Change in disease activity score (DAS28) from Baseline to Week 24; time frame: 24 weeks

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Secondary Outcome

- DAS28 at follow-up; time frame: Up to 2 years
- European league against rheumatism (EULAR) response; time frame: Up to 2 years
- Low DAS28 ( </=3.2) at Week 24; time frame: 24 weeks
- Remission (DAS </=2.6) at Week 24; time frame: 24 weeks
- American College of Rheumatology (ACR) 20/50/70 response; time frame: Up to 2 years
- Short-form (SF-36) health assessment; time frame: Up to 2 years
- Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) assessment; time frame: Up to 2 years
- Health assessment questionnaire (HAQ) disability score; time frame: Up to 2 years
- Swollen/tender joint count; time frame: Up to 2 years
- Global assessment of disease activity; time frame: Up to 2 years
- C-reactive protein (CRP) levels; time frame: Up to 2 years
- Erythrocyte sedimentation rate (ESR); time frame: Up to 2 years
- Rheumatoid factor (RF) level; time frame: Up to 2 years
- Incidence of adverse events; time frame: Up to 2 years

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2006/11/30
  •   302
  •   Multicenter trial
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

- adult patients, 18-75 years of age;

- rheumatoid arthritis for >=6 months;

- previous inadequate response to a single anti-TNF alpha inhibitor;

- methotrexate at a stable dose range 7.5-25 mg/week.

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Exclusion Criteria

- other chronic inflammatory articular disease or systemic autoimmune disease;

- previous treatment with MabThera or intolerance to MabThera;

- corticosteroids>=10 mg/day prednisolone within last 2 weeks, or corticosteroids at
unstable doses within last 2 weeks;

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Addresses

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    • Hoffmann-La Roche
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    • Hoffmann-La Roche
    • Clinical Trials 
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    • Hoffmann-La Roche
    • Clinical Trials 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2011/05/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.