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
Status and phase
Completed
Phase 2
Conditions
Rheumatoid Arthritis
Treatments
Drug: Itacitinib
Drug: Itacitinib Placebo
Details and patient eligibility
About
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.
Enrollment
106 patients
Sex
All
Ages
18 to 75 years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Triple Blind
106 participants in 12 patient groups, including a placebo group
Itacitinib 400 mg twice a day
Experimental group
Description:
Itacitinib 400 mg twice a day
Treatment:
Drug: Itacitinib
Itacitinib 400 mg placebo twice a day
Placebo Comparator group
Description:
Itacitinib 400 mg placebo twice a day
Treatment:
Drug: Itacitinib Placebo
Itacitinib 100 mg twice a day
Experimental group
Description:
This dose group will be studied twice during the study.
Treatment:
Drug: Itacitinib
Itacitinib 100 mg placebo twice a day
Placebo Comparator group
Description:
This dose group will be studied twice during the study.
Treatment:
Drug: Itacitinib Placebo
Itacitinib 100mg once a day
Experimental group
Description:
Itacitinib 100mg once a day
Treatment:
Drug: Itacitinib
Itacitinib 100 mg placebo once a day
Placebo Comparator group
Description:
Itacitinib 100 mg placebo once a day
Treatment:
Drug: Itacitinib Placebo
Itacitinib 200 mg twice a day
Experimental group
Description:
Itacitinib 200 mg twice a day
Treatment:
Drug: Itacitinib
Itacitinib 200 mg placebo twice a day
Placebo Comparator group
Description:
Itacitinib 200 mg placebo twice a day
Treatment:
Drug: Itacitinib Placebo
Itacitinib 300 mg once a day
Experimental group
Description:
Itacitinib 300 mg once a day
Treatment:
Drug: Itacitinib
Itacitinib 300 mg placebo once a day
Placebo Comparator group
Description:
Itacitinib 300 mg placebo once a day
Treatment:
Drug: Itacitinib Placebo
Itacitinib 600 mg once a day
Experimental group
Description:
Itacitinib 600 mg once a day
Treatment:
Drug: Itacitinib
Itacitinib 600 mg placebo once a day
Placebo Comparator group
Description:
Itacitinib 600 mg placebo once a day
Treatment:
Drug: Itacitinib Placebo
Trial contacts and locations
18
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Data sourced from clinicaltrials.gov
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