Clinical trial NCT00779675: Assessment of Long-Term Infliximab for Psoriasis (P05319)
Official title: Real-World Assessment of Long-Term Infliximab Therapy for Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-10-24
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with plaque-type psoriasis in which the treating physician has selected for treatment with infliximab, in accordance with local clinical practices, will be advised about this trial. It is highly recommended that 30% of the participants enrolled be naïve to previous biologic therapy. For example, if a site recruits 10 participants, 3 out of these 10 participants should be naïve to previous biologic therapy.

Brief summary: This is a prospective Phase 4, open-label, non-randomized, observational, multi-center study of infliximab in participants with plaque-type psoriasis to assess the clinical response in real-world practice of long-term maintenance therapy with infliximab 5 mg/kg body weight in a psoriasis population, prescribed in a regimen in accordance with the product monograph (PM) for Canada, the approved summary sheet of product characteristics (SPC) for countries in the European Union (EU), or per label according to local guidelines for all other participating countries.

Detailed description: This study will be conducted in two phases: the 50-week treatment period and the 48-week extended treatment period.

Eligibility criteria: Inclusion Criteria:

* Participant must have a diagnosis of plaque-type psoriasis
* Participant's physician must have decided, with the subject's consent, to start treatment with infliximab
* Participant must demonstrate willingness to participate in the study and agree with the procedures of the study by signing the written informed consent
* For inclusion into the extended treatment period, participant must have completed 50 weeks of infliximab treatment in the treatment period
* For inclusion into the extended treatment period, participant must be continuing treatment with intravenous infliximab
* For inclusion into the extended treatment period, participant must have an improvement in their PASI score of greater than or equal to 25% at the time of entry into to the extended treatment period

Exclusion Criteria:

For the Treatment Period

* Given the non-interventional nature of the study, no specific exclusion criteria will be applied to a participant so long as the participant is eligible for the trial (Inclusion Criteria). The treating physician is expected, as in normal clinical practice, to follow the PM (Canada), the approved SPC (EU), or local labeling (for all other participating countries) regarding contraindications and precautions

For the Extended Treatment Period

* Given the non-interventional nature of the study, no specific exclusion criteria will be applied to a participant so long as the participant is receiving infliximab treatment in accordance with the PM (Canada), the approved SPC (EU), or local labeling (for all other participating countries) regarding contraindications, precautions, dosing and frequency of administration

Primary outcomes:
measure: Number of Participants With a Psoriasis Area Sensitivity Index (PASI)-75 Response at Week 50
timeFrame: Week 50
Secondary outcomes:
measure: Number of Participants With a PASI-90 Response at Week 50 Among Participants With a PASI-90 Response at Week 14
timeFrame: Week 50
measure: Number of Particpants With a PASI-90 or PASI-75 at Week 50 Among Participants With a PASI-75 Response at Week 14
timeFrame: Week 50
measure: Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 50 Among Participants With a PASI-50 Response at Week 14
timeFrame: Week 50
measure: Number of Participants With a PASI-90 Response at Week 98 Among Participants With a PASI-90 Response at Week 50 and Who Entered the Extended Treatment Period
timeFrame: Week 98
measure: Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 98 Among Participants With a PASI-50 Response at Week 50 and Who Entered the Extended Treatment Period
timeFrame: Week 98
measure: Change From Baseline in Mean PASI Score
timeFrame: Baseline, Week 14, Week 30, Week 50, Week 62, Week 78, Week 98
measure: Number of Participants With a PASI-90 or PASI-75 Response at Week 98 Among Participants Who Had a PASI-75 Response at Week 50 and Who Entered the Extended Treatment Phase
timeFrame: Week 98
measure: Change From Baseline in Mean Dermatology Life Quality Index (DLQI)
timeFrame: Baseline, Week 50, Week 62, Week 78, Week 98
measure: Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase
timeFrame: Week 50, Week 62, Week 78, Week 98
measure: Number of Participants With a PASI-50, PASI-75, PASI-90, or PASI-100 Response at Week 98
timeFrame: Week 98
measure: Number of Participants Who Achieved a PASI-75 Response at Week 50 by Age
timeFrame: Week 50
measure: Number of Participants Who Achieved a PASI-75 Response at Week 50 by Gender
timeFrame: Week 50
measure: Number of Participants Who Achieved a PASI-75 Response at Week 50 by Race
timeFrame: Week 50
measure: Number of Participants Who Achieved a PASI-75 Response at Week 50 by the Presence of Nail Psoriasis at Baseline
timeFrame: Week 50
measure: Number of Participants Who Achieved a PASI-75 Response at Week 50 by PASI Score at Baseline
timeFrame: Week 50
Other outcomes:
Locations:
Study officials:
References:
citation: Shear NH, Hartmann M, Toledo-Bahena M, Katsambas A, Connors L, Chang Q, Yao R, Nograles K, Popmihajlov Z; REALITY investigators. Long-term efficacy and safety of infliximab maintenance therapy in patients with plaque-type psoriasis in real-world practice. Br J Dermatol. 2014 Sep;171(3):631-41. doi: 10.1111/bjd.13004. Epub 2014 Aug 13.