A Phase 2, 12-week, double-blind, randomized, parallel group, placebo-controlled study of four doses of Study Medication in subjects with moderate to severe rheumatoid arthritis

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    Recruiting
Updated on 8 November 2020

Summary

A Phase 2, 12-week, double-blind, randomized, parallel group, placebo-controlled study of four doses of Study Medication in subjects with moderate to severe rheumatoid arthritis

Description

This study is designed to evaluate safety and assess initial efficacy of Study Medication, a JAK3 inhibitor, for treatment of subjects with active RA. This study will assess the clinical response of 4 doses of Study Medication compared to placebo when administered for 12 weeks to patients with active RA. The study will also evaluate the safety and tolerability of Study Medication compared to placebo when administered for 12 weeks to subjects with active RA.

Patient Inclusion Criteria:

  • All subjects must have been diagnosed with RA
  • Subjects must have a swollen joint count of =6 out of 28 joints and tender joint count of =6 out of 28 joints.
  • Baseline CRP level must be 1.5 times greater than the upper limit of normal at Screening.
  • Subjects must have failed at least 1 nonbiologic DMARD for any reason.
  • Subjects may have previously failed no more than 1 biologic DMARD and discontinued treatment for reasons other than inadequate response.

Patient Exclusion Criteria:

  • Subjects with inflammatory rheumatological disorders other than RA.
  • History or evidence of a clinically significant disorder other than RA
  • Subjects with clinically important abnormalities in screening physical examination or in screening laboratory test results
  • History of hematologic disorders including neutropenia and thrombocytopenia.
  • Subjects with an acute or chronic active infection requiring systemic antimicrobial treatment.
  • Subjects who require concomitant use of any inhibitors or inducers of cytochrome P450 (CYP) 3A.
  • Subjects who have been treated with intra-articular injections of corticosteroids within 28 days prior to Day 1.
  • Subjects who have planned major surgery or any procedures during the study.
  • Have received any live, attenuated vaccinations within 1 month prior to study drug administration.

Details
Clinical Study IdentifierTX134912
Last Modified on8 November 2020

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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