Scleroderma & Systemic Sclerosis Studies

​The Division of Rheumatology strives to understand more about scleroderma and systemic sclerosis through research.  Please see the list below, which summarizes the studies available to individuals interested in advancing our understanding and treatment of rheumatic disease. 

Study Name/IRB#/PIBrief DescriptionBasic Eligibility Criteria​Contact
MINERAL; Microbiome and Neutrophil associated factors in Rheumatoid Arthritis and Autoimmune-related Interstitial Lung Disease

20-2769

Melissa Griffith, MD
An observational study to investigate the causes of chronic lung disease in rheumatoid arthritis and other autoimmune diseases1. At least 18 years old
2. Falls under one of the following criteria:
a. Diagnosis of scleroderma
b. Diagnosis of idiopathic pulmonary fibrosis (IPF) or interstitial pneumonia with autoimmune features (IPAF)
c. Diagnosis of RA with associated interstitial lung disease
d. Diagnosis of RA with previous lung abnormalities seen on lung scan

 RAStudies@cuanschutz.edu, 303-724-0071

 

CAR-T study in SLE, IIM and SSc

24-0289

Melissa Griffith, MD
A Phase 1, Multicenter, Open-Label Study Of CC-97540 (BMS-986353), CD19-Targeted Nex-T Chimeric Antigen Receptor (CAR) T Cells, in Participants with Severe, Refractory Autoimmune Diseases: Systemic Lupus Erythematosus, idiopathic Inflammatory Myopathy or Systemic Sclerosis
  • Adult women or men (age 18 and above) with confirmed, active SLE, IIM, SSc
  • Fulfilling the 2013 EULAR/ACR classification criteria for probable or definite SSc.
  • Antinuclear Antibody (ANA) positive at screening or prior to screening
  • with diffuse cutaneous SSc meeting the following criteria: Disease duration ≤ 5 years (from onset of first non-Raynaud manifestation) AND mRSS ≥ 15 at screening AND mRSS increase ≥ 3 units or involvement of 1 new body area, or mRSS increase ≥ 2 units in 1 body area over 6 months AND At least one: C-reactive protein ≥ 10·0 mg/L, erythrocyte sedimentation rate ≥ 28 mm/h, OR Health Assessment Questionnaire – Disability Index (HAQ-DI) > 1.0
  • Or participants diagnosed with diffuse or limited cutaneous SSc AND progressive ILD on HRCT and ≤ 5 years duration (from onset of first non-Raynaud manifestation) 
  • AND inadequate response to at least 1 of the following treatments used for at least 3 months: mycophenolate, cyclophosphamide, rituximab, nintedanib, azathioprine, tocilizumab, or IVIG.
  • Other systemic autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren’s syndrome are not excluded.

Chong Pedrick

303-724-7518

Chong.Pedrick@cuanschutz.edu

 

Najeeb Arishi

303-724-7512

Najeeb.Arishi@cuanschutz.edu

 

Mario Farag

303-724-6438

Mario.Farag@cuanschutz.edu

Please note that study status changes frequently and therefore, a listed study may not be actively enrolling. Also, the complete list of inclusion and exclusion criteria for a given study is often not listed due to its length.  A visit to determine an individuals eligibility may be required.  A placebo is an inactive substance or treatment that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.​

Rheumatology (SOM)

CU Anschutz

Barbara Davis Center for Diabetes

1775 North Aurora Court

3102

Aurora, CO 80045


303-724-7605

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