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Recruiting NCT05883371

NCT05883371 IMPACT - AndHealth Autoimmune Research Registry

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Clinical Trial Summary
NCT ID NCT05883371
Status Recruiting
Phase
Sponsor AndHealth
Condition Arthritis, Rheumatoid
Study Type OBSERVATIONAL
Enrollment 2,500 participants
Start Date 2023-06-08
Primary Completion 2023-11-22

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 70 Years
Study Type OBSERVATIONAL
Interventions
Root-cause autoimmune treatment program

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 2,500 participants in total. It began in 2023-06-08 with a primary completion date of 2023-11-22.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

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.

Eligibility Criteria

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

Contact & Investigator

Central Contact

Sonja Horner

✉ shorner@andhealth.com

📞 614-697-3296

Principal Investigator

Myles Spar, MD

PRINCIPAL INVESTIGATOR

AndHealth

Frequently Asked Questions

Who can join the NCT05883371 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Arthritis, Rheumatoid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05883371 currently recruiting?

Yes, NCT05883371 is actively recruiting participants. Contact the research team at shorner@andhealth.com for enrollment information.

Where is the NCT05883371 trial being conducted?

This trial is being conducted at Columbus, United States.

Who is sponsoring the NCT05883371 clinical trial?

NCT05883371 is sponsored by AndHealth. The principal investigator is Myles Spar, MD at AndHealth. The trial plans to enroll 2,500 participants.

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