Description:

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.; ODM derived from: https://clinicaltrials.gov/show/NCT01197534

Link:

https://clinicaltrials.gov/show/NCT01197534

Keywords:
Versions (3) ▾
  1. 1/20/21
  2. 1/21/21
  3. 1/22/21
Copyright Holder:
AstraZeneca
Uploaded on:

January 22, 2021

DOI:
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License:
Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01197534

Eligibility Rheumatoid Arthritis NCT01197534

Inclusion Criteria
Active Rheumatoid Arthritis (RA) diagnosed after the age of 16?
Treatment with one the following disease modifying anti-rheumatic drug: methotrexate, Sulfasalazine, Hydroxychloroquine or Chloroquine?
4 or more swollen joints and 4 or more tender/painful joints (from 28 joint count)and either erythrocyte sedimentation rate (esr) blood result of 28mm/h or more, or c-reactive protein (crp) blood result of 10mg/l or more?
at least one of the following: documented history of positive rheumatoid factor (blood test), current presence of rheumatoid factor (blood test), radiographic erosion within 12 months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test)?
Exclusion Criteria
Pregnant or breastfeeding (applicable for females)?
Poorly controlled hypertension?
liver disease or significant liver function test abnormalities?
certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders?
recent or significant cardiovascular disease?
significant active or recent infection including tuberculosis?
previous failure to respond to a tnf alpha antagonist, anakinra or previous treatment with other biological agent?
severe renal impairment?
neutropenia?