Time | Screening | Week −2 | Week −1 | Week 0 | Week 3 | Week 5 | Every 12 weeks from week 13 up to week 145 | Early termination |
---|---|---|---|---|---|---|---|---|
Enrollment | ||||||||
Informed consent | X | Â | Â | Â | Â | Â | Â | Â |
Demography, medical history | X | Â | Â | Â | Â | Â | Â | Â |
Vital signs and full physical examination | X | Â | Â | X | Â | X | X | X |
Psoriasis Area and Severity Index (PASI) | X | Â | Â | X | Â | X | X | X |
Eligibility criteria | X | Â | Â | Â | Â | Â | Â | Â |
Laboratory assessments | X | Â | X | X | X | X | X | X |
Chest X-ray, Mantoux test, and interferon-gamma release assay (IGRA) | X | Â | Â | Â | Â | Â | Â | Â |
Randomization | X | Â | Â | Â | Â | Â | Â | Â |
Intervention | ||||||||
Adalimumab (Humira) + MTX |  | X (MTX) | X (MTX) | X (Humira + MTX) | ||||
Humira monotherapy | Â | Â | Â | X (Humira) | ||||
Assessments | ||||||||
Laboratory assessments | X | Â | X | X | X | X | X | X |
PASI | X | Â | Â | X | Â | X | X | X |
Physician global assessment | X | Â | Â | X | Â | X | X | X |
Patient global assessment | X | Â | Â | X | Â | X | X | X |
Impact on quality of life (Skindex 29 and Dermatology Life Quality Index (DLQI)) | X | Â | Â | X | Â | X | X | X |
Prior or concomitant therapy | X | Â | Â | X | Â | X | X | X |
Adverse events | X | Â | Â | X | Â | X | X | X |
Drug adherence | Â | Â | Â | X | Â | X | X | X |