Phase
Condition
Rheumatoid Arthritis
Treatment
N/AClinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Subjects will be eligible to participate in the study if they meet all the followingcriteria:
Willing and able to sign an ICF
Age 18 to 80 years at enrollment
Meets the 2010 ACR/EULAR criteria and/or 1987 criteria for RA, as determined by aboard-certified rheumatologist ≥3 months prior to enrollment
Received uninterrupted treatment with weekly MTX begun ≥3 months prior to enrollment,at a stable dose of ≥15 mg per week for at least 4 weeks prior to enrollment. Ahistory of therapy with split dose oral MTX or parenteral MTX is acceptable only ifthe weekly MTX dose was always ≤20 mg/week during the 3 months prior to enrollment.
CDAI >10 as assessed by the Investigator at screening
At least 3 swollen joints (SJC ≥3) and 3 tender joints (TJC ≥3) out of 28 joints asassessed by the Investigator at screening
Must be eligible for treatment intensification with non-biologic and biologic DMARDs
Documented evidence of seropositivity (RF and/or anti-CCP antibodies). Seronegativesubjects are allowed if erosive disease attributable to RA is documented on X-rays.
Exclusion
Exclusion Criteria: Subjects will be ineligible to participate in the study if they meet any of the followingcriteria:
Use of a non-biologic DMARD other than MTX within 3 months prior to enrollment
MTX administered SQ or as an oral split dose at >20 mg/week any time during the 3months prior to enrollment
Two or more DMARDs used in combination (i.e., concomitantly), including but notlimited to: MTX, HCQ, SSZ, LEF, cyclosporine, azathioprine, gold or penicillamine anytime prior to enrollment
Biologic DMARD or JAKi use any time prior to enrollment
Any contraindication to use of MTX, HCQ, LEF or biologic DMARDs
Opiate use during the 2 weeks prior to enrollment
Oral corticosteroids during the month prior to enrollment at a dosage >10 mg/dayprednisone (or equivalent) or at a non-stable dose ≤10 mg/day prednisone (orequivalent)
MTX intolerance prior to enrollment that limits its use
Inflammatory joint disease (other than RA) or any other systemic autoimmune disorder. (Osteoarthritis is not a basis for exclusion.)
Primary or secondary immunodeficiency
Active infection (excluding fungal infection of nail beds); or acute or chronicinfection requiring hospitalization or treatment with parenteral systemic antibioticswithin one month of enrollment or treatment with oral antibiotics within 2 weeks ofenrollment
IA, intravenous or IM corticosteroids during the month prior to enrollment
Initiation or non-stable dosing of NSAIDs within 2 weeks prior to enrollment
Vectra DA testing within 3 months prior to enrollment
Live vaccine within 90 days of enrollment
Active substance abuse or psychiatric illness likely to interfere with protocolconduct
History of severe allergic or anaphylactic reaction to any monoclonal antibody therapy
Known infection with HIV (HIV testing will not be a requirement for trial entry); apast or current history of hepatitis B virus or hepatitis C virus infection
History of malignancy within the past five years or any evidence of persistentmalignancy, except fully excised basal cell or squamous cell carcinomas of the skin,or cervical carcinoma in situ that has been treated or excised in a curative procedure
Pregnancy or inadequate contraception in women of childbearing potential
Breast feeding or lactating
Medical, psychiatric, cognitive or other conditions that, in the opinion of theInvestigator, may compromise the ability of the subject to understand the studyinformation, to give informed consent, to comply with the trial protocol, or tocomplete the study
Presently enrolled in another clinical trial
Vectra DA score at screening that is outside the applicable range as required forsubject enrollment Note: Screening for TB is not required for subjects participating in the study. If anInvestigator is considering a subject for treatment with a biologic DMARD in the study,guidelines for TB screening need to be followed.
Study Design
Study Description
Connect with a study center
Rheumatology Associates of North Alabama PC
Huntsville, Alabama 35801-4414
United StatesActive - Recruiting
Dana Copeland Redyy Rheumatology
Chula Vista, California 91910
United StatesActive - Recruiting
Medvin Clinical Research
Covina, California 91723
United StatesActive - Recruiting
Western Connecticut Health Network
Danbury, Connecticut 06810
United StatesActive - Recruiting
Delaware Arthritis
Lewes, Delaware 19958
United StatesActive - Recruiting
Howard University
Washington, District of Columbia 20060
United StatesSite Not Available
Howard University
Washington, D.C., District of Columbia 20060
United StatesSite Not Available
Robert W. Levin, MD
Clearwater, Florida 33765
United StatesActive - Recruiting
Arthritis Research Associates of Florida
Palm Harbor, Florida 34684
United StatesActive - Recruiting
Kenneth Stark, MD
Tavares, Florida 32778
United StatesActive - Recruiting
Graves Gilbert Clinic
Bowling Green, Kentucky 42101
United StatesActive - Recruiting
Rheumatology Associates of Baltimore
Baltimore, Maryland 21286
United StatesSite Not Available
The Center for Rheumatology and Bone Research
Wheaton, Maryland 20902
United StatesActive - Recruiting
University of Michigan
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Beals institute PC
Lansing, Michigan 48917
United StatesActive - Recruiting
June DO, PC
Lansing, Michigan 48910
United StatesActive - Recruiting
Shores Rheumatology, P.C.
Saint Clair Shores, Michigan 48081
United StatesActive - Recruiting
Shores Rheumatology, P.C.
St. Clair Shores, Michigan 48081
United StatesSite Not Available
North Mississippi Medical Center
Tupelo, Mississippi 38801
United StatesActive - Recruiting
Timothy Kelly, MD
Las Vegas, Nevada 89128
United StatesSite Not Available
Summit Medical Group
Berkeley Heights, New Jersey 07922
United StatesActive - Recruiting
Prospect Medical Offices Valley Medical Group
Midland Park, New Jersey 07432
United StatesActive - Recruiting
Overlook Medical Center Wound Healing Center
Summit, New Jersey 07901
United StatesActive - Recruiting
Overlook Medical Center Wound Healing Center
Summitt, New Jersey 07901
United StatesSite Not Available
Rheumatology Associates of Long Island
Smithtown, New York 11787
United StatesActive - Recruiting
PMG Research of Salisbury
Salisbury, North Carolina 28144
United StatesActive - Recruiting
Carolina Specialty Care
Statesville, North Carolina 28625
United StatesActive - Recruiting
PMG Research of Wilmington
Wilmington, North Carolina 28401
United StatesActive - Recruiting
Paramount Medical Research, LLC
Middleburg Heights, Ohio 44130
United StatesActive - Recruiting
Southern Ohio Rheumatology
Wheelersburg, Ohio 45694
United StatesActive - Recruiting
Dr. Alan Kivitz
Duncansville, Pennsylvania 16635-1018
United StatesActive - Recruiting
Clinical Research Center of Reading, LLC
Wyomissing, Pennsylvania 19610
United StatesActive - Recruiting
Carolina Health Specialist
Myrtle Beach, South Carolina 29572
United StatesActive - Recruiting
University of Tennesee Health Science
Memphis, Tennessee 38104
United StatesSite Not Available
Southwest Rheumatology Research LLC
Mesquite, Texas 75150
United StatesActive - Recruiting
Accurate Clinical Research
Nassau Bay, Texas 77058
United StatesActive - Recruiting
Arthritis Clinic of Central Texas
San Marcos, Texas 78666
United StatesActive - Recruiting
Arthritis Clinic of Northern VA, PC
Arlington, Virginia 22205
United StatesActive - Recruiting
Arthritis & Rheumatic Disease
Burke, Virginia 22015
United StatesActive - Recruiting
Western Washington Arthritis Clinic
Bothell, Washington 98021
United StatesActive - Recruiting
The Polyclinic
Seattle, Washington 98104
United StatesActive - Recruiting
Arthritis Northwest, P.L.L.C
Spokane, Washington 99204
United StatesActive - Recruiting
Gundersen Clinic, Ltd.
Onalaska, Wisconsin 54650
United StatesActive - Recruiting
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