Adherence to Otezla

Psoriasis Clinical Trial

Official title:

Adherence to Otezla in Patients With Mild Psoriasis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05601492
• Other study ID #: IRB00088889
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: July 2024
• Est. completion date: February 2025

Study information

• Verified date: May 2024
• Source: Wake Forest University Health Sciences
• Contact: Irma M Richardson, MHA
• Phone: 336-716-2903
• Email: irichard[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Most people with psoriasis have very limited disease, yet that disease may still have a large impact on their lives. While limited psoriasis may be amenable to topical treatment, patients are exceptionally poorly adherent to topical treatment, especially over the long run.

Description:

Psoriasis patients prefer oral treatments and are more adherent to orals than to topicals, but adherence to oral treatment of psoriasis may still be limited, compromising treatment outcomes. How well the medication works in the patients who take treatment regularly is not well characterized.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Adult 18 years or older

• Diagnosis of mild psoriasis with Otezla recommendation

• Non-pregnant

• English speaking

Exclusion Criteria:

• Under 18 years of age

• Not diagnosis of mild psoriasis

• Pregnant

• Non-English speaking

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Otezla - Standard Care
The participant will be given their medication with the electronic adapter cap on it and asked to return for the follow-up visit

Behavioral:
• Reminder Text Intervention with apremilast
Participants will receive a weekly electronic text/email-based intervention that is designed to promote better adherence to treatment in addition to receiving their medication with the electronic adapter cap on it.
• Extended Consultation for apremilast
Participants will be given their medication with the electronic adapter cap on it and will receive an initial patient consult intervention, which will focus on medication education and setting expectations of what to anticipate with usage of the prescribed medication

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Amgen

Country where clinical trial is conducted

United States, 

References & Publications (5)

Alinia H, Moradi Tuchayi S, Smith JA, Richardson IM, Bahrami N, Jaros SC, Sandoval LF, Farhangian ME, Anderson KL, Huang KE, Feldman SR. Long-term adherence to topical psoriasis treatment can be abysmal: a 1-year randomized intervention study using objective electronic adherence monitoring. Br J Dermatol. 2017 Mar;176(3):759-764. doi: 10.1111/bjd.15085. Epub 2016 Nov 29. — View Citation

Okwundu N, Cardwell LA, Cline AE, Richardson IM, Feldman SR. Adherence to topical treatment can improve treatment-resistant moderate psoriasis. Cutis. 2020 Feb;105(2):89-91;E2;E3. — View Citation

Salisbury KR, Ranpariya VK, Feldman SR. Accountability in reminder-based adherence interventions: A review. Patient Educ Couns. 2022 Aug;105(8):2645-2652. doi: 10.1016/j.pec.2021.12.009. Epub 2021 Dec 15. — View Citation

West C, Narahari S, O'Neill J, Davis S, Huynh M, Clark A, Boles A, Feldman SR. Adherence to adalimumab in patients with moderate to severe psoriasis. Dermatol Online J. 2013 May 15;19(5):18182. — View Citation

Yentzer BA, Wood AA, Sagransky MJ, O'Neill JL, Clark AR, Williams LL, Feldman SR. An Internet-based survey and improvement of acne treatment outcomes. Arch Dermatol. 2011 Oct;147(10):1223-4. doi: 10.1001/archdermatol.2011.277. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Adherence Outlier	Identify adherence outliers (high and low adherence). Adherence will be determined by the data retrieved from the electronic monitor that is placed on the medication bottle to provide the days and times the bottle is opened to take the medication.	Month 6
Secondary	Difference of Efficacy among high adherent subjects	As a secondary outcome, we will compare psoriasis treatment outcomes (efficacy) between the most and least adherent patients. Measures for comparing efficacy between high vs low adherence subjects will be percent of subjects with Investigator Global Assessment (IGA) of clear/almost clear - The IGA is a five-point scale that provides a global clinical assessment of Atopic Dermatitis (AD) severity ranging from 0 to 4, where 0 indicates clear, 2 is mild, 3 is moderate, and 4 indicates severe Atopic Dermatitis (AD). A decrease in score relates to an improvement in signs and symptoms.	Month 6
Secondary	Difference of Safety among low adherent subjects	As a secondary outcome, we will compare psoriasis treatment outcomes (safety) between the most and least adherent patients. Measures for comparing safety between high vs low adherence subjects will be percent of subjects with Investigator Global Assessment (IGA) of clear/almost clear - The IGA is a five-point scale that provides a global clinical assessment of Atopic Dermatitis (AD) severity ranging from 0 to 4, where 0 indicates clear, 2 is mild, 3 is moderate, and 4 indicates severe Atopic Dermatitis (AD). A decrease in score relates to an improvement in signs and symptoms.	Month 6