[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

888-813-8669

Email address

T1DTrials@joslin.harvard.edu

Condition

Type 1 Diabetes Mellitus

Treatment type

Interventional

Investigational product

AVT001

Phase

Phase 1/Phase 2

Sponsor

Avotres Inc.

ClinicalTrials.gov identifier

NCT03895996

Study number

AVT001-T1D-01

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About the study

This is a double-blind, randomized , placebo-controlled study to evaluate the safety and tolerability of AVT001, and to assess AVT001 as a potential treatment for type 1 diabetes (T1D). The trial will involve approximately 24 new-onset T1D subjects.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. GAD65) 2. Insulinoma associated protein 2 (IA-2, also known as ICA-
  2. 512) 3. Zinc transporter 8 (ZnT8). 2. Age 18 or older and able to provide informed consent. 3. If a participant is female with reproductive potential, willing to avoid pregnancy through the duration of the trial. 4. Signed and dated written informed consent. Key
Exclusion criteria
  1. ULN) 6. Screening bilirubin > 2.0 mg / dL 7. Current use of immunosuppressive or immunomodulatory therapies, including pharmacologic doses of systemic steroids. However, topical steroidal creams and inhaled steroids without large systemic absorption are allowed. 8. Coincident medical condition likely to require immunosuppressive or immunomodulatory therapies. 9. Coincident medical condition likely to limit short term (5
  2. year) life expectancy (malignancy, symptomatic coronary artery disease, recent
  3. stroke) 10. Prior radiation therapy, immunotherapy (within 1 year of screening), or chemotherapy 11. Serologic evidence of current HIV-1 or HIV-2 infection 12. Serologic evidence of hepatitis C infection 13. Serologic evidence of acute or chronic active hepatitis B as measured by Core Ab positive and / or Surface Antibody antigen positive 14. Subjects with other autoimmune conditions (except compensated or treated autoimmune thyroid, celiac, alopecia, or vitiligo
  4. diseases) 15. Women who are pregnant (pregnancy testing during screening), breastfeeding, or planning pregnancy during the study period 16. Inadequate venous access to support leukapheresis 17. Any condition that in the opinion of the investigator(
  5. s) would preclude the subject from participating in a clinical trial. 18. Abnormal screening ECG that in the opinion of the investigator or sponsor would pose a safety risk.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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