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Sponsored by: |
Array BioPharma |
Information provided by: | Array BioPharma |
ClinicalTrials.gov Identifier: | NCT00729209 |
Randomized, double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and efficacy of ARRY-371797 given to patients with Rheumatoid Arthritis who are also on stable doses of methotrexate.
Condition | Intervention | Phase |
Rheumatoid Arthritis |
Drug: Placebo Drug: ARRY-371797 100mg, Q12h Drug: ARRY-371797 200mg, Q12h |
Phase I |
MedlinePlus related topics: | Rheumatoid Arthritis |
ChemIDplus related topics: | Methotrexate |
Study Type: | Interventional |
Study Design: | Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Pharmacokinetics Study |
Official Title: | A Phase 1b, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Pharmacokinetics, Safety and Efficacy of ARRY-371797 in Patients With Rheumatoid Arthritis (RA) Receiving Stable Doses of Methotrexate (MTX) |
Estimated Enrollment: | 30 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
ARRY-371797 100mg, Q12h
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Drug: ARRY-371797 100mg, Q12h
ARRY-371797 100mg, Q12h
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3: Placebo Comparator
Placebo
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Drug: Placebo
Placebo comparator
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2: Experimental
ARRY-371797 200mg, Q12h
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Drug: ARRY-371797 200mg, Q12h
ARRY-371797 200mg, Q12h
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosed with RA at least 3 months prior to the Screening visit based upon the American College of Rheumatology (ACR) 1987 Revised Criteria,, fulfilling at least 4 of the following 7 criteria. The first 4 must have been present for at least 6 weeks:
Minimum current level of disease activity characterized by:
a. C-reactive protein (CRP) ≥ 0.8 mg/dL (8 mg/L)
Completed a 4-week washout period (calculated from Day -7) if treated with any of the following therapies:
Patients may continue on stable background therapy for RA (doses should be stable for at least 6 weeks prior to the first dose of study drug, unless the patient stops due to documented disease improvement, with Sponsor approval), only if it is included in the following list:
Exclusion Criteria:
Has received any of the following prior treatments:
Presenting with any of the following:
United States, Alabama | |||||
Clinic for Rheumatic Diseases | Recruiting | ||||
Tuscaloosa, Alabama, United States, 35406 | |||||
Contact: Kris Coss 205-750-0030 crd_coss@hotmail.com | |||||
Principal Investigator: Richard Jones, MD | |||||
United States, Arizona | |||||
Sun Valley Arthritis Center, Ltd | Recruiting | ||||
Peoria, Arizona, United States, 85381 | |||||
Contact: J. Tuber 623-825-5591 ext 237 jtuber@svacltd.com | |||||
Principal Investigator: Joy Schectman, MD | |||||
United States, Arkansas | |||||
Woodland International Research Group | Recruiting | ||||
Little Rock, Arkansas, United States, 72211 | |||||
Contact: Carol Witham 501-221-8681 carol@woodlandintlresearchgrp.com | |||||
Principal Investigator: George Konis, DO | |||||
United States, Illinois | |||||
NUCATS Institute, Northwestern University | Recruiting | ||||
Chicago, Illinois, United States, 60611 | |||||
Contact: Barbara Ferry 312-503-0792 b-ferry@northwestern.edu | |||||
Principal Investigator: Eric Ruderman, MD | |||||
United States, Oklahoma | |||||
Lynn Health Sciences Institute | Recruiting | ||||
Oklahoma City, Oklahoma, United States, 73112 | |||||
Contact: Natacha Arledge 405-602-3957 narledge@lhsi.net | |||||
Principal Investigator: Larry Willis, MD | |||||
United States, South Carolina | |||||
Palmetto Clinical Trial Services | Not yet recruiting | ||||
Greenville, South Carolina, United States, 29601 | |||||
Contact: Kim Williams 864-527-2307 kwilliams@palmettoclinical.com | |||||
Principal Investigator: Josette Johnson, MD | |||||
United States, Texas | |||||
Metroplex Clinical Research Center | Recruiting | ||||
Dallas, Texas, United States, 75219 | |||||
Contact: Sara Hibbard 214-424-0400 shibbard@mcrcdallas.com | |||||
Principal Investigator: Ray Fleischmann, MD |
Array BioPharma |
Responsible Party: | Array BioPharma ( Farran Peterson, Clinical Program Manager ) |
Study ID Numbers: | ARRAY-797-103 |
First Received: | August 4, 2008 |
Last Updated: | September 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00729209 |
Health Authority: | United States: Food and Drug Administration |
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