A Phase 3 interventional study of Infliximab in Psoriasis, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-04-11.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment
Subjects with moderate-to-severe chronic psoriasis not responding to standard or biologic therapy will be eligible to enroll in this study. Subjects will receive infliximab infusions (5 mg/kg of body weight) at Weeks 0, 2, 6, and 14 followed by a 12-week follow-up period. The efficacy of infliximab will be evaluated by the Psoriasis Area and Severity Index (PASI).
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 215 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6, and 14.
Biological: Infliximab
Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
Also known as: Remicade, SCH 215596
Number of Participants Who Achieve a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI) Score
PASI 75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 10. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease).
Time frame: 10 weeks
| Milestone | Infliximab 5 mg/kg |
|---|---|
| Started | 159 |
| Completed | 129 |
| Not completed | 30 |
| Withdrew: Protocol violation | 7 |
| Withdrew: Adverse event | 6 |
| Withdrew: Lack of efficacy | 6 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Did not return for visit | 3 |
| Withdrew: For reasons different from those above | 4 |
PASI 75 response is defined as participants who achieved at least a 75% improvement in PASI score from Baseline to Week 10. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease).
| Participants | Intent to Treat Population | Per Protocol Population |
|---|---|---|
| Number of Participants Who Achieve a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI) Score | 111 | 111 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Infliximab 5 mg/kg | — | 2/159 (1.3%) | 16/159 (10.1%) |
| Event | Infliximab 5 mg/kg |
|---|---|
| pneumonia legionellaInfections and infestations | 1/159 |
| erythemaSkin and subcutaneous tissue disorders | 1/159 |
| Event | Infliximab 5 mg/kg |
|---|---|
| pyrexiaGeneral disorders | 9/159 |
| arthralgiaMusculoskeletal and connective tissue disorders | 8/159 |
| Age, Continuous(years) | Infliximab 5 mg/kg |
|---|---|
| Mean | 44.15 ± 12.80 |
| Sex: Female, Male(Participants) | Infliximab 5 mg/kg |
|---|---|
| Female | 40 |
| Male | 119 |
No study locations are listed for this record.
Plan to share: Yes — http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC