Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-24 @ 9:57 PM
NCT ID:
NCT01156532
Eligibility Criteria:
Inclusion Criteria:
* Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate
* Participant is capable of and willing to give written informed consent and to comply with the requirements of the study protocol
Exclusion Criteria:
* Participants should not be enrolled if they cannot be treated in accordance with the local product label
* Participants enrolled into another study or clinical trial
* History of hepatitis B infection
* History of neurologic symptoms suggestive of central nervous system demyelinating disease
* History of cancer or lymphoproliferative disease (other than successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix)
* Active tuberculosis infection before initiating adalimumab treatment or latent tuberculosis infection not able to take complete prophylactic treatment
* Pregnant or lactating female, demonstrated by a pregnancy test before entering the study and willing to use a contraceptive method
* Use of another anti-tumoral necrosis factor previously
* History of congestive heart failure
* Any other condition that according to the criteria of the participating investigator represents an obstacle for study conduction and/or subjects participants to an unacceptable risk
* Participants with active infection including chronic or localized infections until infections are controlled
* History of sensitivity to latex
* Participants who will receive concomitant phototherapy and systemic therapy during adalimumab therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01156532
Study Brief:
Protocol Section:
NCT01156532