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Clinical Trials/EUCTR2006-006746-33-DE
EUCTR2006-006746-33-DE
Active, not recruiting
Not Applicable

Re-Treatment with Rituximab in patients with rheumatoid arthritis who have had an inadequate response to not more than one aTNF (extension study to ML19070) - Efficacy of re-therapy in anti-TNFalpha IR

Roche Pharma AG0 sites240 target enrollmentStarted: March 12, 2007Last updated:
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ConditionsRheumatoid arthritisMedDRA version: 9.1Level: PTClassification code 10039073Term: Rheumatoid arthritis
DrugsMabThera 500 mg Konzentrat zur Herstellung einer Infusionslösung

Overview

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
240
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1\. Patients with active rheumatoid arthritis (DAS28 \>\=2\.6\) who participated in ML19070 (FIRST trial) and have completed the week 24 visit and who experienced a decrease (between week 16 and 24 in study ML19070\) in DAS28 \> 0\.6
  • •2\.Eligible for re\-treatment by the following criteria:
  • •Swollen joint count \>\=2
  • •Tender joint count \>\=2
  • •3\. Not more than 1 year have passed since the patient’s first rituximab infusion within study ML19070
  • •4\. Not more than one TNF\-alpha\- inhibitor in history
  • •5\.Willingness and capability to give written informed consent, and willingness to participate and to comply with the study
  • •6\. Age range: 18 – 80 years at inclusion date in ML19070
  • •7\. Pregnancy urine test at screening (not earlier than 28 days prior to day 1\)
  • •Are the trial subjects under 18? no

Exclusion Criteria

  • •General exclusion criteria
  • •1\. Patients from ML19070 having received any DMARD except MTX, any TNFalpha inhibitor, leflunomide or any anti\-IL or CTLA4 Ig or any biological or investigational agent after the rituximab infusions
  • •2\. Patients with a response between week 16 and 24 in study ML19070 in DAS28 \<\=0\.6 to rituximab. These Patients will remain in study ML19070 until completion or withdrawal.
  • •Exclusion criteria related to RA
  • •3\. Functional class IV
  • •Exclusion criteria related to general health
  • •4\. Patients with other chronic inflammatory articular disease or systemic autoimmune disease
  • •5\. Any active infection, a history of recurrent clinically significant infection, a history of recurrent bacterial infections with encapsulated organisms
  • •6\. Primary or secondary immunodeficiency
  • •7\. History of cancer with curative treatment not longer than 5 years ago except basal\-cell carcinoma of the skin that had been excised

Investigators

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