Evaluation of the clinical and echographic response to Apremilast through clinical evaluation and through a joint-periarticular-nail echographic index in patients with active psoriatic arthritis.

Phase 1

• Conditions: Psoriasic arthritis; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2017-000901-19-ES
• Lead Sponsor: Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-04
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Adults equal or over 18 years with Psoriatic Arthritis (PAs) according to CASPAR criteria (Classification Criteria for Psoriatic Arthritis) at the time of selection with involvement of hands and / or feet with active clinical disease (more than two inflamed joints)
- To have 2 or more joints with echographic synovitis at the screening visit
- To have 1 or more echographically affected enthesis at the screening visit
- To accept and to sign the informed consent of the study
- Ability to comply with all tests and visits of specified protocol and to have a permanent address.
- Women of childbearing age should have a negative pregnancy test at the baseline visit. Women of childbearing age who participate in the study should use one of the following contraceptive methods throughout the trial and at least up to 28 days after taking the last dose of study medication.
Approved contraceptive options are:
· Option 1: Any of the following: hormonal contraceptives (eg, birth control pills, injection, implant, transdermal patch, vaginal ring); Intrauterine device (IUD); tubal ligation; Or that your partner has had a vasectomy
OR
· Option 2: male or female condom (a latex condom or non-latex condom BUT NOT made of a natural [animal, eg polyurethane] membrane) AND one of the following additional barrier methods: a) Diaphragm with spermicide; B) cervical cap with spermicide; Or c) contraceptive sponge with spermicide.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 56
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Concomitant treatment with methotrexate or leflunomide or other DMARDs. Patients may not have taken methotrexate during the month prior to screening, leflunomide during the 2 months prior to screening and other DMARDs during the 15 days prior to screening.
- Prior or current use of biological therapy (anti-TNF)
-Do not meet any of the inclusion requirements.
- Medical contraindications for taking Apremilast
- Pregnancy or breastfeeding
- History of allergy to any component of the study drug
- Active tuberculosis (TB) or history of incomplete treatment for tuberculosis.
- Substance abuse or history of substance abuse within 6 months prior to screening
- Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks prior to screening.
- Malignancy or history of malignancy (except in situ cutaneous carcinomas of the basal or squamous cells treated (ie, cured) and treated cervical intraepithelial neoplasms or in situ carcinoma of the cervix without evidence of recurrence within The last 5 years)
- Use of systemic corticosteroids at doses> 10 mg / day at the time of screening and 4 weeks before
- Use of potent enzyme inducers of cytochrome CYP3A4 (eg, rifampicin, phenobarbital, carbamazepine, phenytoin, St. John's wort and grapefruit juice) at screening 4 weeks before or during the study
- Use of phototherapy within 4 weeks prior to screening (ie, Ultraviolet B (UVB), psoralen and ultraviolet A (PUVA)
- Use of any investigational drug within 4 weeks prior to screening.
- Pre-treatment with Apremilast

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified