Psoriasis
Conditions
Brief summary
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.
Interventions
DRUGInfliximab
Infliximab 5 mg/kg body weight intravenous infusion given every 6 weeks
DRUGInfliximab and methotrexate
Infliximab 5 mg/kg body weight intravenous infusion (given every 8 weeks) plus methotrexate 7.5 mg orally (once weekly)
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have a diagnosis of moderate to severe plaque-type psoriasis and have had participated in Study P05319. * Subjects must have demonstrated an adequate but suboptimal response to infliximab in Study P05319 * Subjects must be at least 18 years old * Subjects must be candidates for phototherapy or systemic treatment for psoriasis. * Subjects must not be pregnant and must meet contraceptive requirements * Subjects must meet tuberculosis screening criteria * Subjects must meet laboratory and medical history screening requirements
Exclusion criteria
* Subjects for whom infliximab or methotrexate is contraindicated or not recommended. * Subjects already using certain investigational, biological, or immunosuppressive drugs * Subjects with certain comorbid conditions * Subjects who currently have or have a history of certain infections * Subjects who have recently received live virus or bacterial vaccinations * Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With A Psoriasis Area and Sensitivity Index (PASI)-75 Response at Week 28 | Baseline, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With A PASI-90 Response at Week 28 | Baseline, 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. |
| Number of Participants With A PASI-100 Response at Week 28 | Baseline, 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. |
| Number of Participants With A PASI-50 Response at Week 28 | Baseline, 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. |
| Dermatology Life Quality Index (DLQI) at Week 28 | 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. |
| Euro-Qol 5 Dimension (EQ-5D) Change From Baseline at Week 28 | Baseline, 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. |
| Change From Baseline in Mean Participant Raw PASI Scores at Week 28 | Baseline, 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. |
Participant flow
Recruitment details
Multicenter: 48 centers in Australia, Belgium, Colombia, Canada, Denmark, France, Germany, Greece, Hungary, Italy, and Russia.
Pre-assignment details
Of the 39 participants that were randomized to the study, 3 (2 Infliximab \[IFX\] q 6 weeks; and 1 IFX + Methotrexate \[MTX\]) participants did not meet protocol eligibility criteria and were excluded from the efficacy analysis.
Participants by arm
| Arm | Count |
|---|---|
| IFX q 6 Weeks Infliximab 5 mg/kg administered every 6 weeks. | 17 |
| IFX q 8 Weeks + MTX Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly. | 19 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 0 |
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | Treatment Failure | 3 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | IFX q 6 Weeks | IFX q 8 Weeks + MTX | Total |
|---|---|---|---|
| Age, Continuous | 45.3 years STANDARD_DEVIATION 15.38 | 48.2 years STANDARD_DEVIATION 17.03 | 46.8 years STANDARD_DEVIATION 16.11 |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 12 Participants | 14 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 18 | 6 / 19 |
| serious Total, serious adverse events | 1 / 18 | 0 / 19 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IFX q 6 Weeks | Number of Participants With A Psoriasis Area and Sensitivity Index (PASI)-75 Response at Week 28 | 9 Participants |
| IFX q 8 Weeks + MTX | Number of Participants With A Psoriasis Area and Sensitivity Index (PASI)-75 Response at Week 28 | 11 Participants |
Secondary
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
Population: The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.
Secondary
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
Population: The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.
Secondary
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
Population: The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.
Secondary
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
Population: The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.
Secondary
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
Population: The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.
Secondary
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
Population: The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.