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.
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.
You may not be if
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:
Aminosalicylates including mesalamine/ mesalazine (Asacol, Pentasa).
Thiopurines including azathioprine (Imuran) and 6-mercaptopurine (Purixan)
Systemic JAK inhibitors including tofacitinib (Xeljanz), abrocitinib (Cibinqo), baricitinib (Olumiant), upadacitinib (Rinvoq)
CD52 inhibitors including alemtuzumab (Campath)
Methotrexate
Cladribine
Teriflunomide (Aubagio)
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.
Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
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.
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.
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.
Clareo Health | A Biospecimen Collection Study to Identify the Targets of Disease-Reactive T Cells in Patients With Autoimmune Disease
