Psoriasic arthritis
Conditions
Sponsors
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To obtain a 20% reduction in the echographic index at 12 months after the introduction of Apremilast in study patients;Primary end point(s): A reduction in echographic index at 12 months after the introduction of Apremilast in the study patients (12-month echographic index-baseline echographic index) / baseline echographic index;Secondary Objective: - To obtain a reduction of 50 and 70% in the echographic index at 12 months after the introduction of Apremilast in the study patients - To evaluate the nail echographic lesions associated to PA - To detect nail changes in relation to treatment with Apremilast - To correlate the nail changes with the changes in the articular/enthesis echographic index. - To correlate the echographic variables - Changes in the nº of swollen and painful joints - Patient EVA (0-100 mm) or VGP, EVA medical (0-100 mm) - Changes in the index of LEI - Changes in the PCR and VSG - Evaluation of HLA B-27, peptids anti CCP and rheumatoid factor;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - DAS 28, CDAI and SDAI indices - Psoriasis Activity and Severity Index (PASI) - Leeds Enthesitis Index (LEI). - Number of painful and inflamed joints assessed by (NAD and NAI or NAT) - Evaluation of pain using the patient EVA scale or VGP and medical EVA or VGM - Associated macrophage-associated nail injuries - Diffuse thickening or patching of the nail ventral lamina - Increased thickness of the nail bed;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Spain
Contacts
Public ContactJuan José de agustín de Oro
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
Outcome results
None listed