Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007341

Trial Description

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Title

A Randomized, Open-label Study of the Effect of MabThera Retreatment on Treatment Response in Patients With Rheumatoid Arthritis

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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 assess the long-term safety and efficacy of repeating treatment with
MabThera, in combination with methotrexate and steroids, in patients who we re previously
randomized into studies WA16291 or WA17043. The anticipated time o n study treatment is
until Mabthera is available on the local market and the tar get sample size is 100-500
individuals.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007341
  •   2015/10/05
  •   2014/03/19
  •   no
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Secondary IDs

  •   NCT02093026  (ClinicalTrials.gov)
  •   WA16855  (Hoffmann-La Roche)
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Health Condition or Problem studied

  •   Rheumatoid Arthritis
  •   M06 -  Other rheumatoid arthritis
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Interventions/Observational Groups

  •   Drug: methylprednisolone
  •   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)
  •   II
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Primary Outcome

- Efficacy: Proportion of patients with an ACR20 response achieved by retreatment\n\n; time frame: Approximately 5 years

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Secondary Outcome

- Proportion of patients reaching an ACR50 response; time frame: Approximately 5 years
- Proportion of patients reaching an ACR70 response; time frame: Approximately 5 years
- Proportion of patients with a EULAR response; time frame: Approximately 5 years
- Change in disease activity score (DAS28) from baseline; time frame: Approximately 5 years
- Change in American college of rheumatology score (ACR) from baseline; time frame: Approximately 5 years
- Change in total rheumatoid factors (RF) from baseline; time frame: Approximately 5 years
- Proportion of patients discontinuing treatment due to insufficient response; time frame: Approximately 5 years
- Time since last treatment course; time frame: Approximately 5 years
- Incidence of adverse events; time frame: Approximately 5 years

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Countries of Recruitment

  •   United States
  •   Australia
  •   Belgium
  •   Brazil
  •   Canada
  •   Czech Republic
  •   Finland
  •   Germany
  •   Israel
  •   Italy
  •   Mexico
  •   New Zealand
  •   Poland
  •   Spain
  •   Sweden
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2002/08/31
  •   472
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   21   Years
  •   no maximum age
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Additional Inclusion Criteria

- adult patients, >=21 years of age, with active RA;

- completed 24 weeks of treatment in WA16291 or WA17043;

- eligible for re-treatment, based on clinical symptoms;

- females of childbearing potential using reliable contraception.

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Exclusion Criteria

- patients who participated in MabThera studies WA16291 or WA17043 but withdrew into
the safety follow-up phases of these trials;

- current treatment with any other disease-modifying drug (apart from methotrexate), or
any anti-TNFalfa, anti-IL1, or other biologic therapies;

- development of any new contraindications to receiving MabThera;

- female patients who are pregnant or breastfeeding.

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Addresses

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    • Hoffmann-La Roche
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    • Genentech, Inc.
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    •   [---]*
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  • start of 1:1-Block address scientific-contact
    • 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
  •   2013/10/01
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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.