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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01626573

Enrollment

106

Registered

2012-06-22

Start date

2012-03-31

Completion date

2013-10-31

Last updated

2019-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, RA, Active

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.

Interventions

DRUGItacitinib

DRUGItacitinib Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
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.	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.	Approximately 84 days.

Secondary

Measure	Time frame	Description
Preliminary Pharmacokinetic (PK) collections.	Following 15 days of therapy.	Plasma concentrations of itacitinib will be used to estimate peak plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC).

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026