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
Overview
- Phase
- Phase 2
- Intervention
- Itacitinib
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Incyte Corporation
- Enrollment
- 106
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a study evaluating a 28-day course followed by a 56-day course of itacitinib in patients with active rheumatoid arthritis (RA). The study will evaluate safety and efficacy parameters of itacitinib.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Itacitinib 400 mg twice a day
Itacitinib 400 mg twice a day
Intervention: Itacitinib
Itacitinib 400 mg placebo twice a day
Itacitinib 400 mg placebo twice a day
Intervention: Itacitinib Placebo
Itacitinib 100 mg twice a day
This dose group will be studied twice during the study.
Intervention: Itacitinib
Itacitinib 100 mg placebo twice a day
This dose group will be studied twice during the study.
Intervention: Itacitinib Placebo
Itacitinib 100mg once a day
Itacitinib 100mg once a day
Intervention: Itacitinib
Itacitinib 100 mg placebo once a day
Itacitinib 100 mg placebo once a day
Intervention: Itacitinib Placebo
Itacitinib 200 mg twice a day
Itacitinib 200 mg twice a day
Intervention: Itacitinib
Itacitinib 200 mg placebo twice a day
Itacitinib 200 mg placebo twice a day
Intervention: Itacitinib Placebo
Itacitinib 300 mg once a day
Itacitinib 300 mg once a day
Intervention: Itacitinib
Itacitinib 300 mg placebo once a day
Itacitinib 300 mg placebo once a day
Intervention: Itacitinib Placebo
Itacitinib 600 mg once a day
Itacitinib 600 mg once a day
Intervention: Itacitinib
Itacitinib 600 mg placebo once a day
Itacitinib 600 mg placebo once a day
Intervention: Itacitinib Placebo
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Preliminary Pharmacokinetic (PK) collections.(Following 15 days of therapy.)