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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01626573 |
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Date of registration:
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03/05/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study Exploring the Safety, Tolerability, and Efficacy of a 28 Day Course Followed by an Additional 56 Day Course of Itacitinib in Subjects With Active Rheumatoid Arthritis
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Scientific title:
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A Double- Blind, Placebo Controlled Study Exploring the Safety, Tolerability, and Efficacy of a 28 Day Course Followed by an Additional 56 Day Course of Itacitinib in Subjects With Active Rheumatoid Arthritis |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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106 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01626573 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Puerto Rico
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United States
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Contacts
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Name:
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Victor Sandor, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Incyte Corporation |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects with active RA aged 18 to 75 years of age and meet tender and swollen joint
assessment expectations defined in the study protocol.
- c-Reactive protein (CRP) or erythrocyte sedimentation rate (ESR) laboratory values
meet minimal study protocol expectations.
Exclusion Criteria:
- Females who are pregnant or breastfeeding.
- Men and women who cannot comply with requirements to avoid fathering a child or
becoming pregnant, respectively.
- Subjects treated with a biologic agent within 12 weeks prior to first dose of study
drug. (12 months in the case of rituximab.)
- Subjects with a history or currently suspected inflammatory disease other than RA.
- Subjects with a history of hematological disorders.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Itacitinib
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Drug: Itacitinib Placebo
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Primary Outcome(s)
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Preliminary efficacy as assessed by the percentage of patients achieving ACR20 improvement from baseline on the day 28 and day 84 visits.
[Time Frame: Approximately 84 days.]
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Safety and tolerability of itacitinib as assessed by the changes in frequency and severity of adverse events, ECGs, vital signs, physical examinations, and clinical laboratory evaluations.
[Time Frame: Approximately four months.]
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Secondary Outcome(s)
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Preliminary Pharmacokinetic (PK) collections.
[Time Frame: Following 15 days of therapy.]
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Secondary ID(s)
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39110-201
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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