Status:

WITHDRAWN

A Study to Assess the Pharmacokinetics of Methotrexate Given With and Without AZD9056 in Rheumatoid Arthritis Patients

Lead Sponsor:

AstraZeneca

Conditions:

Rheumatoid Arthritis

Eligibility:

All Genders

18-70 years

Phase:

PHASE1

Brief Summary

The main aim of this clinical study is to investigate whether the blood concentration of methotrexate changes when AZD9056 is co- administered together with methotrexate.

Eligibility Criteria

Inclusion

  • Patients diagnosed with rheumatoid arthritis
  • Currently on Methotrexate treatment
  • Provision of informed consent

Exclusion

  • History of malignancy (except for treated squamous and basal cell carcinoma of the skin more than 5 years prior to entry)
  • Patients who were taking prescription of medications listed below:
  • Medications that are hepatic enzyme inducers and that were inhibitors of cytochrome P450, Lovastatin
  • Leflunomide, hydroxychloroquine, cyclosporin or anti-tumour necrosis factor therapies within 90 days of Visit 1, or treatment with rituximab within 1 year before Visit 1

Key Trial Info

Start Date :

May 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2009

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT00920608

Start Date

May 1 2009

End Date

September 1 2009

Last Update

December 3 2010

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