Trial Outcomes & Findings for Dose Optimization of Infliximab in Moderate to Severe Plaque Psoriasis (Study P05315) (NCT NCT00833053)
NCT ID: NCT00833053
Last Updated: 2017-04-12
Results Overview
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.
TERMINATED
PHASE3
39 participants
Baseline, Week 28
2017-04-12
Participant Flow
Multicenter: 48 centers in Australia, Belgium, Colombia, Canada, Denmark, France, Germany, Greece, Hungary, Italy, and Russia.
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.
Participant milestones
| Measure |
IFX q 6 Weeks
Infliximab 5 mg/kg administered every 6 weeks.
|
IFX q 8 Weeks + MTX
Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
|
Overall Study
COMPLETED
|
10
|
17
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
| Measure |
IFX q 6 Weeks
Infliximab 5 mg/kg administered every 6 weeks.
|
IFX q 8 Weeks + MTX
Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
|
Overall Study
Treatment Failure
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
1
|
Baseline Characteristics
Dose Optimization of Infliximab in Moderate to Severe Plaque Psoriasis (Study P05315)
Baseline characteristics by cohort
| Measure |
IFX q 6 Weeks
n=17 Participants
Infliximab 5 mg/kg administered every 6 weeks.
|
IFX q 8 Weeks + MTX
n=19 Participants
Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 15.38 • n=93 Participants
|
48.2 years
STANDARD_DEVIATION 17.03 • n=4 Participants
|
46.8 years
STANDARD_DEVIATION 16.11 • n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 28The 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.
Outcome measures
| Measure |
IFX q 6 Weeks
n=17 Participants
Infliximab 5 mg/kg administered every 6 weeks.
|
IFX q 8 Weeks + MTX
n=19 Participants
Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
|
|---|---|---|
|
Number of Participants With A Psoriasis Area and Sensitivity Index (PASI)-75 Response at Week 28
|
9 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 28Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 28Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 28Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 28Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 28Population: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
IFX q 6 Weeks
IFX q 8 Weeks + MTX
Serious adverse events
| Measure |
IFX q 6 Weeks
n=18 participants at risk
Infliximab 5 mg/kg administered every 6 weeks.
|
IFX q 8 Weeks + MTX
n=19 participants at risk
Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Psoriasis Aggravated
|
5.6%
1/18 • Number of events 2
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
0.00%
0/19
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
Other adverse events
| Measure |
IFX q 6 Weeks
n=18 participants at risk
Infliximab 5 mg/kg administered every 6 weeks.
|
IFX q 8 Weeks + MTX
n=19 participants at risk
Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
5.6%
1/18 • Number of events 2
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
0.00%
0/19
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.00%
0/18
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • Number of events 1
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
0.00%
0/19
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
|
General disorders
Chest Discomfort
|
5.6%
1/18 • Number of events 1
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
0.00%
0/19
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
|
General disorders
Infusion Related Reaction
|
5.6%
1/18 • Number of events 1
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/18
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
2/18 • Number of events 2
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
0.00%
0/19
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Oral Herpes
|
5.6%
1/18 • Number of events 2
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
0.00%
0/19
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Rash Pustular
|
0.00%
0/18
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Renal Abscess
|
5.6%
1/18 • Number of events 1
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
0.00%
0/19
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/18
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
10.5%
2/19 • Number of events 4
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/18
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Urinary Tract Infection
|
5.6%
1/18 • Number of events 1
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
0.00%
0/19
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Arthropod Sting
|
0.00%
0/18
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/18
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/18
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasm
|
5.6%
1/18 • Number of events 2
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
0.00%
0/19
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Hypotonia
|
5.6%
1/18 • Number of events 1
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
0.00%
0/19
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
|
Reproductive system and breast disorders
Vaginal Inflammation
|
0.00%
0/18
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
1/18 • Number of events 2
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
0.00%
0/19
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
5.6%
1/18 • Number of events 1
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
0.00%
0/19
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
1/18 • Number of events 1
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalized
|
5.6%
1/18 • Number of events 1
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
0.00%
0/19
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/18
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
5.3%
1/19 • Number of events 1
Safety analyses were performed on all randomized subjects who took at least one dose of study medication.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60