Treatments Against RA and Effect on FDG-PET/CT

Study Purpose

In a randomized controlled clinical trial, investigators will compare the effects on [18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) from two treatment regimens in rheumatoid arthritis (RA) patients deemed methotrexate inadequate responders (MTX-IRs). Two common RA treatments will be compared: triple therapy (sulfasalazine, methotrexate, and hydroxychloroquine) versus tumor necrosis factor (TNF) inhibitor (etanercept or adalimumab, plus background methotrexate for all subjects and hydroxychloroquine for subjects who were taking this at screening).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 45 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Fulfill American College of Rheumatology/European League Against Rheumatism 2010 criteria for RA - Men ≥ 45 years and women ≥ 50 years - MTX monotherapy for ≥ 8 weeks at ≥ 15mg weekly or ≥ 7.5 mg weekly with a documented intolerance to higher doses - No non-biologic DMARDs in preceding two months (other than MTX and HCQ) - Disease Activity Score-28 > 3.2 - Able to sign informed consent

Exclusion Criteria:

- Use of biologic DMARD within the past 6 months or use of rituximab ever - Current use of >10mg per day of prednisone - Use of a high-intensity statin lipid lowering drug or PCSK9 inhibitor in the past 12 months - Prior patient reported, physician diagnosed clinical cardiovascular (CV) event - Insulin-dependent or uncontrolled diabetes mellitus (DM) - Systemic lupus erythematosus (SLE) or other autoimmune and chronic inflammatory diseases (i.e. inflammatory bowel disease, sarcoidosis) - Cancer treated in the last 5 years (except basal and squamous cell) or any lymphoma or melanoma - Known pregnancy, HIV, Hepatitis B Virus, Hepatitis C Virus, active (or untreated latent) tuberculosis - Baseline: liver, renal or blood count abnormalities, Glucose-6-phosphate dehydrogenase (G6PD) deficiency - Known sulfa allergy, macular disease or hypersensitivity to treatments; known demyelinating disease; uncompensated Congestive Heart Failure (CHF) - Intra-articular injection within the 4 weeks prior to baseline FDG PET/CT - 2 or more high dose radiation scans in the past year (CT scan with contrast, angiogram, SPECT nuclear medicine scan, myocardial/cardiac perfusion scan)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02374021
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Brigham and Women's Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Daniel Solomon
Principal Investigator Affiliation Brigham and Women's Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Arthritis, Rheumatoid
Study Website: View Trial Website
Additional Details

Consenting subjects will be screened for eligibility and randomized to a treatment arm. Subjects will be randomized to a treatment arm with either synthetic disease-modifying antirheumatic drugs (DMARDs) [triple therapy: sulfasalazine, methotrexate, and hydroxychloroquine] or biologic DMARDs [etanercept or adalimumab, plus background methotrexate for all subjects and hydroxychloroquine for subjects who were taking this at screening]. Once randomized, a baseline visit will be conducted with each subject. Baseline data collection includes questionnaires, disease activity score, and the first FDG-PET/CT imaging. After the baseline at week 0, subjects will visit with their rheumatologist at weeks 6, 12, 18, and 24 for safety labs and further collection of disease activity scores and questionnaires. The second FDG-PET/CT will be performed at week 24. Blood specimens will be collected at weeks 0, 6, 18, and 24 for bioassays. Subject participation will end after the week 24 visit. Patients and care providers will be unblinded. The FDG-PET/CT image readers will be blinded to treatment arm as well as timepoint of image acquisition.

Arms & Interventions

Arms

Active Comparator: Triple therapy (MTX+SSZ+HCQ)

Sulfasalazine (SSZ) 1 g bid and hydroxychloroquine (HCQ) 200 mg twice daily, not to exceed 6.5mg/kg HCQ (in addition to concomitant methotrexate [MTX]).

Active Comparator: TNF inhibitor (etanercept or adalimumab)

etanercept 50 mg subcutaneously weekly or adalimumab 40 mg subcutaneously every other week (in addition to concomitant methotrexate, plus hydroxychloroquine, for subjects who were taking this at screening). Biologic treatment will be assigned randomly.

Interventions

Drug: - Methotrexate

Subjects entering trial will continue on MTX dose of at least 15mg MTX/week. At the discretion of the treating rheumatologist, may be switched to SQ route.

Drug: - Sulfasalazine

1 gm bid

Drug: - Hydroxychloroquine

200 mg twice daily, not to exceed 6.5mg/kg

Drug: - Etanercept

50 mg SC weekly

Drug: - Adalimumab

40 mg SQ every other week

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294

Site Contact

Laticia Woodruff, RN

[email protected]

205-934-9843

Loma Linda, California

Status

Recruiting

Address

Loma Linda University Clinical Trial Center

Loma Linda, California, 92354

Site Contact

Melissa Rundquist

[email protected]

909-558-5830

David Geffen School of Medicine at UCLA, Los Angeles, California

Status

Recruiting

Address

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095

Site Contact

Jeraldine Guzman

[email protected]

Brigid Freyne, MD Inc., Murrieta, California

Status

Recruiting

Address

Brigid Freyne, MD Inc.

Murrieta, California, 92563

Site Contact

Brigid Freyne, MD

[email protected]

951-696-4600

Desert Medical Advances, Palm Desert, California

Status

Recruiting

Address

Desert Medical Advances

Palm Desert, California, 92260

Site Contact

Shannon Lopez

[email protected]

760-341-6800

University of California San Francisco, San Francisco, California

Status

Recruiting

Address

University of California San Francisco

San Francisco, California, 94110

Site Contact

Alex Carvidi

[email protected]

Nazanin Firooz MD, Inc., West Hills, California

Status

Recruiting

Address

Nazanin Firooz MD, Inc.

West Hills, California, 91307

Site Contact

Sharzad Firooz

[email protected]

818-598-0000

Robert W. Levin, MD, PA, Clearwater, Florida

Status

Recruiting

Address

Robert W. Levin, MD, PA

Clearwater, Florida, 33765

Site Contact

Lori Androsiglio

[email protected]

727-734-6631

IRIS Research and Development, Plantation, Florida

Status

Recruiting

Address

IRIS Research and Development

Plantation, Florida, 33324

Site Contact

Diane Chambers

[email protected]

954-476-2338 #218

Tampa, Florida

Status

Recruiting

Address

Southwest Florida Clinical Research Center

Tampa, Florida, 33609

Site Contact

Katherine Athime

[email protected]

813-879-1188 #103

University of Kentucky, Lexington, Kentucky

Status

Recruiting

Address

University of Kentucky

Lexington, Kentucky, 40508

Site Contact

Dianne Richeson

[email protected]

859-323-2093

Wheaton, Maryland

Status

Recruiting

Address

The Center for Rheumatology and Bone Research

Wheaton, Maryland, 20902

Site Contact

Megan Lormore

[email protected]

301-942-6610

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Site Contact

Seth Brownmiller

[email protected]

617-643-5691

Brigham and Women's Hospital, Boston, Massachusetts

Status

Recruiting

Address

Brigham and Women's Hospital

Boston, Massachusetts, 02115

Site Contact

Fengxin Lu

[email protected]

617-525-8786

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

Site Contact

Stacey Anderson

[email protected]

734-998-1271

Washington University Medical Center, Saint Louis, Missouri

Status

Recruiting

Address

Washington University Medical Center

Saint Louis, Missouri, 63110

Site Contact

Kelly Streckfuss, RN

[email protected]

314-362-7306

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire

Status

Recruiting

Address

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756

Site Contact

Jill Brooker, RN

[email protected]

603-650-4717

Northwell Health, Great Neck, New York

Status

Recruiting

Address

Northwell Health

Great Neck, New York, 11021

Site Contact

Preeya Nandkumar

[email protected]

516-708-2556

New York University School of Medicine, New York, New York

Status

Recruiting

Address

New York University School of Medicine

New York, New York, 10003

Site Contact

Luz Alvarado

[email protected]

646-577-3555

Mount Sinai- Icahn School of Medicine, New York, New York

Status

Recruiting

Address

Mount Sinai- Icahn School of Medicine

New York, New York, 10029

Site Contact

Garnette Mason, MPH

[email protected]

212-241-4824

Columbia University Medical Center, New York, New York

Status

Recruiting

Address

Columbia University Medical Center

New York, New York, 10032

Site Contact

Rachel Broderick

[email protected]

212-342-2713

Chapel Hill, North Carolina

Status

Recruiting

Address

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

Site Contact

Shruti Saxena Beem

[email protected]

919-966-0545

Cleveland Clinic, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Site Contact

MacKenzie Dunlap

[email protected]

216-444-7474

Oregon Health & Science University, Portland, Oregon

Status

Recruiting

Address

Oregon Health & Science University

Portland, Oregon, 97329

Site Contact

Kim Phung Nguyen

[email protected]

503-494-5571

Altoona Research Center, Duncansville, Pennsylvania

Status

Recruiting

Address

Altoona Research Center

Duncansville, Pennsylvania, 16635

Site Contact

Kim Gates

[email protected]

814-693-0300 #143

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Site Contact

Criswell Lavery

[email protected]

215-662-6335

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15261

Site Contact

Laurie Hope, RN

[email protected]

412-647-2638

Metroplex Clinical Research Center, Dallas, Texas

Status

Recruiting

Address

Metroplex Clinical Research Center

Dallas, Texas, 75231

Site Contact

Angi Cox

[email protected]

214-879-6737 #1411

Houston, Texas

Status

Recruiting

Address

University of Texas Health Science Center at Houston

Houston, Texas, 77030

Site Contact

Reyna Chavez

[email protected]

713-500-6870

Temple, Texas

Status

Recruiting

Address

Baylor Scott & White Medical Center- Temple

Temple, Texas, 76508

Site Contact

Sergio Michel

[email protected]

512-550-0714

Seattle Rheumatology Associates, Seattle, Washington

Status

Recruiting

Address

Seattle Rheumatology Associates

Seattle, Washington, 98122

Site Contact

Cathy Loeffler

[email protected]

206-386-2007