Trial document





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

  DRKS00007286

Trial Description

start of 1:1-Block title

Title

An Open Label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNFa Therapies

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

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 were previously
randomized into MabThera study WA17042. The anticipated time on study treatment is until
Mabthera is available on the local market and the target sample size is 100-500 individuals.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

[---]*

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00007286
  •   2016/02/19
  •   2014/03/20
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT02097745  (ClinicalTrials.gov)
  •   WA17531  (Hoffmann-La Roche)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Rheumatoid Arthritis
  •   M05 -  Seropositive rheumatoid arthritis
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: rituximab [MabThera/Rituxan]
  •   Drug: methotrexate
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   [---]*
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Proportion of patients with an American College of Rheumatology (ACR) 20% improvement in pre-specified RA signs and symptoms (ACR20) response; time frame: Up to 5 years

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Proportion of patients achieving an ACR50 and ACR70 response; time frame: Up to 5 years
- Incidence of adverse events; time frame: Up to 5 years
- Proportion of patients who have a European League Against Rheumatism (EULAR) response; time frame: Up to 5 years
- Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR); time frame: 5 years

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   United States
  •   Belgium
  •   Canada
  •   France
  •   Germany
  •   Ireland
  •   Israel
  •   Italy
  •   Netherlands
  •   Norway
  •   United Kingdom
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
  •  
  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2004/06/30
  •   341
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- adult patients 18-80 years of age with active RA;

- patients who participated in MabThera study WA17042, and completed to at least the
Week 24 visit;

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

- patients of reproductive potential must be using reliable contraceptive methods.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- patients who participated in MabThera study WA17042 but withdrew into the safety
follow-up;

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

- development of any new contraindications to receiving MabThera;

- women who are pregnant or breast-feeding.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Hoffmann-La Roche
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Biogen Idec
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Hoffmann-La Roche
    • Clinical Trials 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Hoffmann-La Roche
    • Clinical Trials 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2013/06/01
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
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.