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A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis

Information source: Incyte Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: INCB018424 (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Incyte Corporation

Official(s) and/or principal investigator(s):
Monica Luchi, MD, Study Director, Affiliation: Incyte Corporation

Summary

The purpose of this study is to understand the safety and tolerability of INCB018424 in patients with rheumatoid arthritis

Clinical Details

Official title: A Double-blind, Placebo-controlled Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement

Secondary outcome:

The Percentage of Subjects Achieving ACR 50 Improvement

The Percentage of Subjects Achieving ACR 70 Improvement

Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score

Change From Baseline in Disease Activity Score 28 (DAS 28) CRP Score

Percentage of Subjects Who Achieved DAS 28 ESR Low Disease

Percentage of Subjects Who Achieved DAS 28 CRP Low Disease

Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease

Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Established diagnosis of rheumatoid arthritis 2. Patients receiving methotrexate must be treated with for at least 6 months and receiving a stable weekly dose between 10 and 25 mg for at least 8 consecutive weeks prior to study entry. Exclusion Criteria: 1. Patients who have taken the following drugs within the timeframe below:

- Leflunomide, infliximab, etanercept, adalimumab, abatacept, or other biological

therapies (except rituximab) - Within 12 weeks prior to the first dose of study

medication;

- Rituximab - Within 12 months prior to the first dose of study medication;

- Disease-modifying anti-rheumatic drugs (DMARDs) or other anti-rheumatic

therapies not specified above including but not limited to: gold, penicillamine, dapsone, azathioprine, 6-mercaptopurine, chlorambucil, cyclophosphamide,

cyclosporin, mycophenolate mofetil - Within 12 weeks prior to the first dose of

study medication; 2. Treatment with any investigational medication within 12 weeks prior to the first dose of study medication.

Locations and Contacts

Elblag, Poland

Konskie, Poland

Warszawa, Poland

Huntsville, Alabama 35801, United States

Upland, California 91786, United States

Gainesville, Florida 32607, United States

Palm Harbor, Florida 34684, United States

Kalispell, Montana 59901, United States

Hickory, North Carolina 28601, United States

Mayfield Village,, Ohio 44143, United States

Middleburg Heights, Ohio 44130, United States

Perrysburg, Ohio 43551, United States

Pittsburgh, Pennsylvania 15261, United States

Hixson, Tennessee 37343, United States

Memphis, Tennessee 38119, United States

Additional Information

Starting date: October 2007
Last updated: March 9, 2015

Page last updated: August 23, 2015

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