Optimising adalimumab treatment in psoriasis with concomitant methotrexate.

Phase 1

• Conditions: psoriasis; MedDRA version: 20.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2013-004918-18-BE
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-08
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•Have a diagnosis of moderate to severe plaque psoriasis (PASI=8 at time of screening);
•Is a candidate for the treatment with biologic drugs according to the pertaining guidelines;
•Willing and able to use an adequate contraceptives during the study (all men and pre-menopausal women);
•Adalimumab therapy will be started for the treatment of psoriasis
•Signed informed consent.

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 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

•History of significant MTX or adalimumab toxicity, intolerability or contraindication
•Prior treatment with adalimumab
•Age < 18 years;
•Pregnant and nursing women.
•-other immunosuppressive medication (prednisone, mycofenolaatmofetyl (Cellcept e.g.), ciclosporine (Neoral e.g.), sirolimus (Rapamune), systemic tacrolimus (Prograft e.g.) e.g.)

Study & Design

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