Treatment With Apremilast in Patients With Psoriatic Arthritis

NCT02558361 | Withdrawn Phase 4

• 1 other identifier: PRO00023672
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Apremilast (Otezla®) is a Federal Drug Administration (FDA)-approved treatment for psoriatic arthritis and psoriasis. Although there are a lot of data demonstrating how apremilast works in the laboratory, there are very few demonstrating how it works in the actual target organ, i.e. the skin or synovial (joint) tissue in patients with psoriasis and psoriatic arthritis. Laboratory data has demonstrated that apremilast decreases inflammatory proteins and increases anti-inflammatory proteins. However, almost all of these data/studies have been performed on the blood of patients with psoriasis and psoriatic arthritis, not the skin or synovial (joint) tissue. These studies that have been performed on the blood of patients with this condition may, or may not, reflect the true response to therapy in the synovial (joint) tissue and/or skin.

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Comparison of the change in the specific 32 gene products as measured by RT-PCR from baseline to Month 3 on synovial, skin samples (Co-primary endpoints) using the sign test.

  To be assessed by a change from baseline to month three

Secondary Outcomes (1)

• Comparison of the change in the RT-PCR gene products from baseline to Month 3 on blood samples (sign test).

  To be assessed by a change from baseline to month three

Other Outcomes (3)

• Comparison of the change in the RT-PCR gene products from baseline to month 1 on skin samples (sign test).

  To be assessed by a change from baseline to month three

• Comparison of the change in the RT-PCR gene products of lesional skin to normal skin at baseline (sign test).

  To be assessed by a change from baseline to month three

• Comparison of a change in all the markers of disease activity from baseline to month 3 (sign tests).

  To be assessed by a change from baseline to month three

Study Arms (1)

Open label, single arm

OTHER

Baseline visit:assess disease activity,synovial tissue biopsy of the knee with active synovitis \[target joint\] and punch skin biopsy of a target psoriatic plaque. Perform a similar punch skin biopsy on adjacent normal skin. Start apremilast (standard dosing). Perform venipuncture: blood samples will be obtained for routine studies, quantitative RT-PCR \& ex vivo cytokine production assays. UA/pregnancy test. Month 1: assess disease active , monitor for AE's; repeat punch skin biopsy of target psoriatic plaque. Blood samples will be obtained for RT-PCR and ex vivo cytokine production assays. Month 3: same as month 1; repeat synovial tissue biopsy from target knee joint and punch skin biopsy on target psoriatic plaque. Blood samples for RT-PCR ex vivo cytokine production assays and routine studies.

Drug: Treatment with Apremilast

Interventions

Treatment with Apremilast DRUG

Standard dosing with apremilast (Otezla) will be used. \[30mg po BID after initial titration\]

Also known as: Otezla

Open label, single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must satisfy the following criteria to be enrolled in the study:
• Must be in general good health (except for psoriatic arthritis and psoriasis) as judged by the Investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
• Patients at least 18 years of age with PsA (must meet CASPAR Criteria) and PsO.
• Active knee synovitis (target joint)
• Active psoriatic plaque (target skin lesion)
• Not currently taking or previously on Otezla
• Cannot be on concurrent biologics
• Females of childbearing potential (FCBP)† must have a negative pregnancy test at Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive§ options described below:
• Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural \[animal\] membrane \[for example, polyurethane\]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
• Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural \[animal\] membrane \[for example, polyurethane\]) while on investigational product and for at least 28 days after the last dose of investigational product.
• † A female of childbearing potential is a sexually mature female who 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been postmenopausal for at least 24 consecutive months (that is, has had menses at any time during the preceding 24 consecutive months).
• § The female subject's chosen form of contraception must be effective by the time the female subject is randomized into the study (for example, hormonal contraception should be initiated at least 28 days before randomization).

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment:
• Other than psoriatic arthritis, any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
• Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
• Prior history of suicide attempt at any time in the subject's life time prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
• Pregnant or breast feeding.
• Active substance abuse or a history of substance abuse within 6 months prior to Screening.
• Malignancy or history of malignancy, except for:
• treated \[ie, cured\] basal cell or squamous cell in situ skin carcinomas; treated \[ie, cured\] cervical intraepithelial neoplasia (CIN) or carcinoma in situ of cervix with no evidence of recurrence within the previous 5 years.
• Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
• Prior treatment with apremilast.
• Currently treated with a biologic (TNFi)

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

Morsani Center for Advanced healthcare

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Therapeutics; apremilast

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• John D Carter, MD

  University of South Florida Morsani College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2015
• First Posted: September 24, 2015
• Study Start: April 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 21, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)