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Treatments Against RA and Effect on FDG-PET/CT (TARGET)

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ClinicalTrials.gov Identifier: NCT02374021
Recruitment Status : Recruiting
First Posted : February 27, 2015
Last Update Posted : December 7, 2018
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
Daniel H. Solomon, M.D.,MPH, Brigham and Women's Hospital

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: Methotrexate Drug: Sulfasalazine Drug: Hydroxychloroquine Drug: Etanercept Drug: Adalimumab Phase 4

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatments Against RA and Effect on FDG-PET/CT (The TARGET Trial)
Study Start Date : July 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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]).
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.
Other Name: Rheumatrex

Drug: Sulfasalazine
1 gm bid
Other Name: Azulfidine

Drug: Hydroxychloroquine
200 mg twice daily, not to exceed 6.5mg/kg
Other Name: Plaquenil

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.
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.
Other Name: Rheumatrex

Drug: Etanercept
50 mg SC weekly
Other Name: enbrel

Drug: Adalimumab
40 mg SQ every other week
Other Name: Humira




Primary Outcome Measures :
  1. Change from Baseline in Vascular Inflammation as measured by FDG-PET/CT at 6 months [ Time Frame: 0, 6 months ]


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374021


Contacts
Contact: Daniel H Solomon dsolomon@partners.org
Contact: Joan Bathon jmb2311@columbia.edu

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Sponsors and Collaborators
Brigham and Women's Hospital
Columbia University
Investigators
Principal Investigator: Daniel Solomon Brigham and Women's Hospital

Additional Information:
Responsible Party: Daniel H. Solomon, M.D.,MPH, Chief, Section of Clinical Sciences, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02374021     History of Changes
Other Study ID Numbers: 2014P002747
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

Keywords provided by Daniel H. Solomon, M.D.,MPH, Brigham and Women's Hospital:
rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Hydroxychloroquine
Etanercept
Adalimumab
Sulfasalazine
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal