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IMPACT - AndHealth Autoimmune Research Registry

A

AndHealth

Status

Enrolling

Conditions

Psoriasis
Arthritis, Psoriatic
Ankylosing Spondylitis
Autoimmune Diseases
Arthritis, Rheumatoid

Treatments

Other: Root-cause autoimmune treatment program

Study type

Observational

Funder types

Industry

Identifiers

NCT05883371
044-AND

Details and patient eligibility

About

This is a patient research registry aimed at evaluating the effectiveness of a comprehensive, root-cause medical approach ("AndHealth program") for autoimmune disorders. This approach involves a combination of pharmacological and non-pharmacological therapies offered under the care of a licensed physician with the support of health coaches. While protocol guidance is provided, the therapeutic approach is personalized to the individual needs of patients. The autoimmune disorders of focus in this registry include rheumatoid arthritis, psoriatic arthritis, psoriasis and ankylosing spondylitis. A variety of validated labs, patient-reported outcomes, and medication usage will be assessed among participating patients over a period of up to five years to evaluate the long-term effectiveness of this approach.

Enrollment

2,500 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Adults 18 to 70 years of age
  2. Able to understand and write English
  3. Voluntarily consent to the study and understand its nature and purpose including potential risks and side effects
  4. Documented diagnosis and current use/recommendation for biologic or DMARD medications to treat rheumatoid arthritis, psoriatic arthritis, psoriasis, or ankylosing spondylitis.

Exclusion criteria

  1. Pregnant, breastfeeding, or planning to become pregnant in the next 12 months
  2. Advanced liver or kidney disease
  3. Previous organ transplant or awaiting organ transplant
  4. Actively being treated for cancer
  5. Poorly-controlled mental illness (i.e., schizophrenia, bipolar, current eating disorder)
  6. Has a terminal illness
  7. Current opioid use

Trial contacts and locations

1

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Central trial contact

Sonja Horner

Data sourced from clinicaltrials.gov

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