A Biospecimen Collection Study to Identify the Targets of Disease-Reactive T Cells in Patients With Autoimmune Disease

Prior treatment

• On treatment with drugs that are known to be T cell toxic and cannot be held for at least 4 weeks or longer. The following treatments are not allowed except in designated cohorts when approved by Sponsor:
• Glucocorticoids including prednisone, methylprednisolone (Solu-medrol), budesonide (Entocort), hydrocortisone (Solu-cortef), dexamethasone (Decadron), betamethasone (Betaject)
• Systemic JAK inhibitors including tofacitinib (Xeljanz), abrocitinib (Cibinqo), baricitinib (Olumiant), upadacitinib (Rinvoq)
• CD52 inhibitors including alemtuzumab (Campath)
• Concurrent disease or condition that would make the patient inappropriate for study participation, or any serious medical or psychiatric disorder that would interfere with the subject's safety.
• Patients receiving research biopsy procedures will not have a history of serious or life-threatening allergic reaction to local anesthetics (i.e., lidocaine, xylocaine), if local anesthetic is required for the procedure or to medications used for sedation during a procedure.

Other illness

• Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
• Any other medical or psychiatric condition, which in the opinion of the patient's treating clinician, would make participation in this protocol unreasonably hazardous for the patient.

Other

• Sulfasalazine (Azulfidine)
• Aminosalicylates including mesalamine/ mesalazine (Asacol, Pentasa).
• Thiopurines including azathioprine (Imuran) and 6-mercaptopurine (Purixan)
• Methotrexate
• Cladribine
• Teriflunomide (Aubagio)
• Pregnant or nursing women are excluded because there may be unanticipated adverse events and increased risk to both mother and fetus in the setting of local anesthetic or study procedures.

• Study cohorts 1,2,3,4,5,6,7,8.9: Known or suspected diagnosis, with subsequent diagnostic confirmation, of one of the following cohorts associated with the following autoimmune diseases:
• Inflammatory Bowel Diseases - Crohn's Disease or ulcerative colitis
• Celiac disease
• Ankylosing spondylitis or Non radiographic axial spondyloarthritis (nr-axSpA)
• Multiple sclerosis
• Scleroderma
• Systemic sclerosis with pulmonary involvement
• Other autoimmune disease (as agreed between Investigator and Sponsor)
• Apparent evolving autoimmune disease
• Frozen cryopreserved
• Age equal or greater than 18 years at time of informed consent.
• Ability to understand and willingness to sign an informed consent document when informed consent is required by an ethical review board.
• On disease-modifying treatments that are not known to be directly T cell toxic.
  • Such treatments are allowed and include:
• Non-steroidal anti-inflammatory drugs including aspirin, ibuprofen, acetaminophen, celecoxib, indomethacin, diclofenac, etodolac, naproxen, meloxicam, sulindac, nabumetone amongst others.
• Tumor necrosis factor alpha (TNF-alpha) antagonists including infliximab (Remicade), adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), golimumab (Simponi) and biosimilar drugs with the same generic name.
• Interleukin-12/23 antagonists including ustekinumab (Stelara) and risankizumab-rzaa (Skyrizi)
• Alpha-4-integrin antagonists including vedolizumab (Entyvio), natalizumab (Tysabri)
• Interleukin-17 inhibitors including secukinumab (Cosentyx), ixekizumab (Taltz)
• Recombinant interferon beta
• CD20 antagonists including rituximab (Rituxan), ocrelizumab (Ocrevus), ofatumumab (Kesimpta)
• Oral fumarates including dimethyl fumarate (Tecfidera), diroximel fumarate (Vumerity), monomethyl fumarate (Bafiertam)
• Oral sphingosine 1-phosphate receptor (S1PR) modulators including fingolimod (Gilenya), siponimod (Mayzent), ozanimod (Zeposia), ponesimod (Ponvory)
• Oral glatiramer acetate (copolymer 1; Copaxone)
• Patient is an appropriate candidate for a procedure to obtain a biopsy, tissue samples or biologic materials during a clinically indicated procedure where it is expected that excess materials could be used for research OR
• In the opinion of the clinical investigator, a patient is an appropriate, low-risk candidate for a research only procedure to obtain a biopsy, tissue samples or biologic materials.

Criteria the registry did not label

• Cohort Legend: Cohort 1: Inflammatory Bowel Diseases - Crohn's Disease or Ulcerative Colitis, Cohort 2: Celiac Disease, Cohort 3: Ankylosing spondylitis or non-radiographic axial spondyloarthritis (nr-axSpA), Cohort 4: Multiple Sclerosis, Cohort 5: Scleroderma, Cohort 6: Systemic Sclerosis with pulmonary involvement, Cohort 7: Other Autoimmune Disease, Cohort 8: Apparent Evolving Autoimmune Disease, Cohort 9: Frozen Cryopreserved