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Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response

NCT ID: NCT03414502
Registry status: Recruiting
Study type: Interventional
Phase: Phase 3
Sponsor: University of Nebraska
Conditions: Rheumatoid Arthritis

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Treatment of Rheumatoid Arthritis With Disease-modifying Antirheumatic Drugs (DMARDs): Predictors of Response

Enrollment: 400 participants (Estimated).

What is being studied

Drug: Abatacept
Intervention: Abatacept
Intervention: Adalimumab
Drug: Adalimumab
Intervention: Amides
Intervention: Amino Acids, Peptides, and Proteins
Intervention: Aminopterin
Intervention: Aminoquinolines
Intervention: Antibodies
Intervention: Antibodies, Monoclonal
Intervention: Antibodies, Monoclonal, Humanized
Intervention: Antibodies, Monoclonal, Murine-Derived
Drug: Azathioprine
Intervention: Azathioprine
Intervention: Azoles
Intervention: baricitinib
Drug: Baricitinib
Intervention: Blood Proteins
Drug: Certolizumab
Intervention: Certolizumab Pegol
Intervention: Chloroquine
Drug: Etanercept
Intervention: Etanercept
Intervention: Globulins
Intervention: golimumab
Drug: Golimumab
Intervention: Heterocyclic Compounds
Intervention: Heterocyclic Compounds, 1-Ring
Intervention: Heterocyclic Compounds, 2-Ring
Intervention: Heterocyclic Compounds, Fused-Ring
Intervention: Hydrocarbons
Intervention: Hydrocarbons, Aromatic
Intervention: Hydrocarbons, Cyclic
Intervention: Hydroxychloroquine
Drug: Hydroxychloroquine
Intervention: Immunoconjugates
Intervention: Immunoglobulin Constant Regions
Intervention: Immunoglobulin Fab Fragments
Intervention: Immunoglobulin Fc Fragments
Intervention: Immunoglobulin Fragments
Intervention: Immunoglobulins
Intervention: Immunoproteins
Intervention: Infliximab
Drug: Infliximab
Intervention: Isoxazoles
Drug: Leflunomide
Intervention: Leflunomide
Intervention: Macromolecular Substances
Intervention: Membrane Proteins
Intervention: Mercaptopurine
Intervention: Methotrexate
Drug: Methotrexate
Drug: Minocycline
Intervention: Minocycline
Intervention: Naphthacenes
Intervention: Nucleic Acids, Nucleotides, and Nucleosides
Intervention: Nucleosides
Intervention: Organic Chemicals
Intervention: Peptide Fragments
Intervention: Peptides
Intervention: Polycyclic Aromatic Hydrocarbons
Intervention: Polycyclic Compounds
Intervention: Polyethylene Glycols
Intervention: Polymers
Intervention: Proteins
Intervention: Pteridines
Intervention: Pterins
Intervention: Purines
Intervention: Quinolines
Intervention: Receptors, Cell Surface
Intervention: Receptors, Cytokine
Intervention: Receptors, Immunologic
Intervention: Receptors, Tumor Necrosis Factor
Drug: Rituximab
Intervention: Rituximab
Intervention: sarilumab
Drug: Sarilumab
Intervention: Serum Globulins
Drug: Sulfasalazine
Intervention: Sulfasalazine
Intervention: Sulfonamides
Intervention: Sulfones
Intervention: Sulfur Compounds
Intervention: Tetracyclines
Intervention: Thionucleosides
Intervention: tofacitinib
Drug: Tofacitinib

Who may be eligible

Ages: 19 Years to no maximum
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

INCLUSION CRITERIA: * Diagnosed rheumatoid arthritis (RA) with 4 of 7 American College of Rheumatology criteria * Morning stiffness for at least 1 hour for at least 6 weeks * Swelling of 3 or more joints for at least 6 weeks * Swelling of wrist, metacarpophalangeal (MCP), or proximal interphalangeal joints for 6 or more weeks * Symmetric joint swelling * Hand x-rays with erosions or bony decalcifications * RA nodules * Rheumatoid factor (RF) positive * \>19 yrs old at RA diagnosis * Active disease with at least 1 swollen joint * Starting new DMARD medication(s) (abatacept, adalimumab, azathioprine, barcitinib, certolizumab, etanercept, golimumab, hydroxychloroquine, infliximab, leflunomide, methotrexate, minocycline, rituximab, sarilumab, sulfasalazine, tofacitinib) * If on other DMARDS, must be on stable dose for ≥ 6 wks * If on glucocorticoids, must be on stable dose for 2 wks (\< 10mg of Prednisone/day or equivalent) * Able to adhere to study visit schedule: enrollment (8 wks \& 16 wks +/- 2 wks) * Hemoglobin (Hgb) \> 9g/dl * Platelets \>100 * Creatinine \<1.6 * Aspartate transferase (AST) or alanine aminotransferase (ALT) at or below 1.2 x upper limit * Albumin up to 1.0 g/dL below lower limit of normal EXCLUSION CRITERIA: * Pregnant or breastfeeding women * Men and women of child bearing potential unwilling to practice effective method of contraception

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

Nebraska, United States: 1

Sample of listed locations

University of Nebraska Medical Center — Omaha, Nebraska, 68198, United States — Recruiting

Study details

Start date: December 10, 2007
Primary completion date: March 1, 2028
Completion date: March 1, 2029
First posted: January 30, 2018

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT03414502
Registry last updated: June 17, 2026
QualifiedStudies registry data refreshed: October 2, 2026
QualifiedStudies record fetched: October 2, 2026

View NCT03414502 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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