A Phase 3 interventional study of Infliximab and Infliximab and methotrexate in Psoriasis, sponsored by Merck Sharp & Dohme LLC. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-12.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Treatment
Participants from an ongoing observational study (P05319) who have a limited (adequate but less than optimal) response to infliximab will be randomized to either increase the frequency of infliximab infusions from every 8 weeks to every 6 weeks, or to add weekly methotrexate to their current treatment plan. While receiving infliximab study treatment(s), patients in this study will attend regularly scheduled office visits for various clinical tests for safety and effectiveness evaluations.
1,928 studies on the registry are indexed under Psoriasis; 234 are open to participants now.
This study's enrollment of 39 is below the median of 70 across 1,472 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.
Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug: Infliximab
Drug: Infliximab and methotrexate
Infliximab 5 mg/kg body weight intravenous infusion given every 6 weeks
Also known as: Remicade, SCH 215596
Drug pages: Infliximab · Methotrexate
Infliximab 5 mg/kg body weight intravenous infusion (given every 8 weeks) plus methotrexate 7.5 mg orally (once weekly)
Also known as: Remicade, SCH 215596
Number of Participants With A Psoriasis Area and Sensitivity Index (PASI)-75 Response at Week 28
The Psoriasis Area and Sensitivity Index (PASI) is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline.
Time frame: Baseline, Week 28
Number of Participants With A PASI-50 Response at Week 28
The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity.The PASI-50 response indicates the number of participants achieving a 50% reduction compared to baseline in PASI score.
Time frame: Baseline, Week 28
Number of Participants With A PASI-90 Response at Week 28
The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-90 response indicates the number of participants achieving a 90% reduction compared to baseline in PASI score.
Time frame: Baseline, Week 28
Number of Participants With A PASI-100 Response at Week 28
The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-100 response indicates the number of participants achieving a 100% reduction compared to baseline in PASI score.
Time frame: Baseline, Week 28
Change From Baseline in Mean Participant Raw PASI Scores at Week 28
The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity.
Time frame: Baseline, Week 28
Dermatology Life Quality Index (DLQI) at Week 28
The DLQI is a 10-item questionnaire. Scores range from 0-10 with 0 indicating high quality of life and 10 indicating poor quality of life.
Time frame: Week 28
Euro-Qol 5 Dimension (EQ-5D) Change From Baseline at Week 28
The EQ-5D is a descriptive system comprised of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Participants are asked to indicate his/her health state by selecting the most appropriate statement in each of the 5 dimensions. This selection results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1-5 have no arithmetic properties and should not be used as a cardinal score.
Time frame: Baseline, Week 28
Multicenter: 48 centers in Australia, Belgium, Colombia, Canada, Denmark, France, Germany, Greece, Hungary, Italy, and Russia.
| Milestone | IFX q 6 Weeks | IFX q 8 Weeks + MTX |
|---|---|---|
| Started | 19 | 20 |
| Completed | 10 | 17 |
| Not completed | 9 | 3 |
| Withdrew: Adverse event | 4 | 0 |
| Withdrew: Treatment failure | 3 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Protocol violation | 2 | 1 |
The Psoriasis Area and Sensitivity Index (PASI) is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline.
| Participants | IFX q 6 Weeks | IFX q 8 Weeks + MTX |
|---|---|---|
| Number of Participants With A Psoriasis Area and Sensitivity Index (PASI)-75 Response at Week 28 | 9 | 11 |
The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity.The PASI-50 response indicates the number of participants achieving a 50% reduction compared to baseline in PASI score.
No measurements were reported for this outcome.
The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-90 response indicates the number of participants achieving a 90% reduction compared to baseline in PASI score.
No measurements were reported for this outcome.
The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-100 response indicates the number of participants achieving a 100% reduction compared to baseline in PASI score.
No measurements were reported for this outcome.
The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity.
No measurements were reported for this outcome.
The DLQI is a 10-item questionnaire. Scores range from 0-10 with 0 indicating high quality of life and 10 indicating poor quality of life.
No measurements were reported for this outcome.
The EQ-5D is a descriptive system comprised of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Participants are asked to indicate his/her health state by selecting the most appropriate statement in each of the 5 dimensions. This selection results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1-5 have no arithmetic properties and should not be used as a cardinal score.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IFX q 6 Weeks | — | 1/18 (5.6%) | 8/18 (44.4%) |
| IFX q 8 Weeks + MTX | — | 0/19 (0%) | 6/19 (31.6%) |
| Event | IFX q 6 Weeks | IFX q 8 Weeks + MTX |
|---|---|---|
| Psoriasis AggravatedSkin and subcutaneous tissue disorders | 1/18 | 0/19 |
| Event | IFX q 6 Weeks | IFX q 8 Weeks + MTX |
|---|---|---|
| NasopharyngitisInfections and infestations | 2/18 | 0/19 |
| SinusitisInfections and infestations | 0/18 | 2/19 |
| VertigoEar and labyrinth disorders | 1/18 | 0/19 |
| NauseaGastrointestinal disorders | 1/18 | 0/19 |
| Chest DiscomfortGeneral disorders | 1/18 | 0/19 |
| Infusion Related ReactionGeneral disorders | 1/18 | 1/19 |
| Oral HerpesInfections and infestations | 1/18 | 0/19 |
| Renal AbscessInfections and infestations | 1/18 | 0/19 |
| Urinary Tract InfectionInfections and infestations | 1/18 | 0/19 |
| Muscle SpasmMusculoskeletal and connective tissue disorders | 1/18 | 0/19 |
| Age, Continuous(years) | IFX q 6 Weeks | IFX q 8 Weeks + MTX | Total |
|---|---|---|---|
| Mean | 45.3 ± 15.38 | 48.2 ± 17.03 | 46.8 ± 16.11 |
| Sex: Female, Male(Participants) | IFX q 6 Weeks | IFX q 8 Weeks + MTX | Total |
|---|---|---|---|
| Female | 5 | 5 | 10 |
| Male | 12 | 14 | 26 |
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.
The record gives a start of Oct 2009, a primary completion of Apr 2011 and a completion of Apr 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2012, 1 year 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Infliximab · Methotrexate