Trial Outcomes & Findings for Long-Term Effects of Infliximab in the Treatment of Moderate to Severe Psoriasis [Extension of Study P04271, NCT00251641] (P04563) (NCT NCT00358670)
NCT ID: NCT00358670
Last Updated: 2017-04-11
Results Overview
PASI75 defined as the number of participants who achieved a \>=75% improvement in Psoriasis Area and Severity Index (PASI) from the original Baseline in Study P04271 (NCT00251641).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
441 participants
Primary outcome timeframe
128 weeks
Results posted on
2017-04-11
Participant Flow
Participant milestones
| Measure |
Maintenance Infliximab
Infliximab 5 mg/kg by body weight every 8 weeks
|
Intermittent Infliximab
Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in Psoriasis Area and Severity Index (PASI) from the Study P04271 (NCT00251641) Baseline
|
|---|---|---|
|
Overall Study
STARTED
|
222
|
219
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
222
|
219
|
Reasons for withdrawal
| Measure |
Maintenance Infliximab
Infliximab 5 mg/kg by body weight every 8 weeks
|
Intermittent Infliximab
Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in Psoriasis Area and Severity Index (PASI) from the Study P04271 (NCT00251641) Baseline
|
|---|---|---|
|
Overall Study
Adverse Event
|
26
|
29
|
|
Overall Study
Lack of Efficacy
|
20
|
23
|
|
Overall Study
Protocol Violation
|
6
|
9
|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
|
Overall Study
Withdrawal by Subject
|
13
|
24
|
|
Overall Study
Protocol Defined Clinical Event
|
0
|
1
|
|
Overall Study
Did Not Meet Protocol Eligibility
|
0
|
3
|
|
Overall Study
Administrative
|
153
|
125
|
Baseline Characteristics
Long-Term Effects of Infliximab in the Treatment of Moderate to Severe Psoriasis [Extension of Study P04271, NCT00251641] (P04563)
Baseline characteristics by cohort
| Measure |
Maintenance Infliximab
n=222 Participants
Infliximab 5 mg/kg by body weight every 8 weeks
|
Intermittent Infliximab
n=219 Participants
Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
|
Total
n=441 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.7 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
43.3 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
44.5 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
152 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
308 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 128 weeksPopulation: Due to the early termination of the study, no subjects completed 128 weeks of therapy.
PASI75 defined as the number of participants who achieved a \>=75% improvement in Psoriasis Area and Severity Index (PASI) from the original Baseline in Study P04271 (NCT00251641).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 52 weeksPopulation: Descriptive summary of all randomized subjects who completed 52 weeks (+ or - 4 weeks) of therapy. Based on best (minimum) PASI score at Week 52.
PASI75 defined as the number of participants who achieved a \>=75% improvement in PASI from the original Baseline in Study P04271 (NCT00251641)
Outcome measures
| Measure |
Maintenance Infliximab
n=101 Participants
Infliximab 5 mg/kg by body weight every 8 weeks
|
Intermittent Infliximab
n=83 Participants
Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
|
|---|---|---|
|
Number of Participants Who Achieved PASI75 Response at Week 52
|
81 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: 100 WeeksPopulation: Descriptive summary of all randomized subjects who completed 100 weeks (+ or - 4 weeks) of therapy. Based on best (minimum) PASI score at Week 100.
PASI75 defined as the number of participants who achieved a \>=75% improvement in PASI from the original Baseline in Study P04271 (NCT00251641)
Outcome measures
| Measure |
Maintenance Infliximab
n=21 Participants
Infliximab 5 mg/kg by body weight every 8 weeks
|
Intermittent Infliximab
n=13 Participants
Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
|
|---|---|---|
|
Number of Participants Who Achieved PASI75 Response at Week 100
|
18 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 0 to 180 daysPopulation: Participants with at least two post Study P04563 randomization PASI scores (at least one is 150 days or more from Study P04563 randomization).
The PASI 6-month AUC is a time adjusted total PASI score over the 6 month (180 days) period. The AUC is a continuous measurement (not a score on a scale); a lower value is considered better and a higher value is considered worse. The weighted average PASI score over 6 months (using all available PASI scores during a 6 month period \[from Day 0 to 180 days\]) is obtained by using PASI 6-month AUC /180 days.
Outcome measures
| Measure |
Maintenance Infliximab
n=186 Participants
Infliximab 5 mg/kg by body weight every 8 weeks
|
Intermittent Infliximab
n=183 Participants
Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
|
|---|---|---|
|
PASI 6-month Area Under the Curve (AUC); (Time Adjusted Total PASI Score Over the 6 Month Period)
|
566.2 6-month PASI AUC
Standard Error 51.22
|
1098.0 6-month PASI AUC
Standard Error 53.48
|
SECONDARY outcome
Timeframe: Day 0 to 360 daysPopulation: Participants with at least two post Study P04563 randomization PASI scores (at least one is 330 days or more from Study P04563 randomization).
The PASI 12-month AUC is a time adjusted total PASI score over the 12 month (360 days) period. The AUC is a continuous measurement (not a score on a scale); and a lower value is considered better. The weighted average PASI score over 12 months (using all available PASI scores during a 12 month period \[from Day 0 to 360 days\]) is is obtained by using PASI 12-month AUC /360 days.
Outcome measures
| Measure |
Maintenance Infliximab
n=105 Participants
Infliximab 5 mg/kg by body weight every 8 weeks
|
Intermittent Infliximab
n=91 Participants
Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
|
|---|---|---|
|
PASI 12-month AUC (Time Adjusted Total PASI Score Over the 12 Month Period)
|
860.7 12-month PASI AUC
Standard Error 92.46
|
2214.2 12-month PASI AUC
Standard Error 108.5
|
Adverse Events
Maintenance Infliximab
Serious events: 24 serious events
Other events: 95 other events
Deaths: 0 deaths
Intermittent Infliximab
Serious events: 23 serious events
Other events: 97 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Maintenance Infliximab
n=222 participants at risk
|
Intermittent Infliximab
n=219 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/222
|
0.46%
1/219 • Number of events 1
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/222
|
0.46%
1/219 • Number of events 1
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/222
|
0.46%
1/219 • Number of events 1
|
|
Eye disorders
MACULAR HOLE
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/222
|
0.46%
1/219 • Number of events 1
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/222
|
0.46%
1/219 • Number of events 1
|
|
General disorders
CHEST DISCOMFORT
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
General disorders
CHEST PAIN
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
General disorders
HYPOTHERMIA
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
General disorders
INFUSION RELATED REACTION
|
0.45%
1/222 • Number of events 1
|
3.7%
8/219 • Number of events 10
|
|
General disorders
POLYSEROSITIS
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
Infections and infestations
ABSCESS JAW
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
Infections and infestations
ACUTE TONSILLITIS
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
Infections and infestations
DISSEMINATED TUBERCULOSIS
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
Infections and infestations
DIVERTICULITIS
|
0.90%
2/222 • Number of events 2
|
0.00%
0/219
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/222
|
0.46%
1/219 • Number of events 1
|
|
Infections and infestations
GASTROINTESTINAL INFECTION
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
Infections and infestations
INFECTION
|
0.00%
0/222
|
0.46%
1/219 • Number of events 1
|
|
Infections and infestations
INFLUENZA
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
Infections and infestations
PNEUMONIA
|
0.90%
2/222 • Number of events 2
|
0.00%
0/219
|
|
Infections and infestations
PULMONARY TUBERCULOSIS
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.00%
0/222
|
0.46%
1/219 • Number of events 1
|
|
Infections and infestations
TONSILLITIS
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
ALCOHOL POISONING
|
0.45%
1/222 • Number of events 2
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
Injury, poisoning and procedural complications
MENISCUS LESION
|
0.45%
1/222 • Number of events 2
|
0.00%
0/219
|
|
Investigations
BIOPSY PROSTATE
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/222
|
0.46%
1/219 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.90%
2/222 • Number of events 2
|
0.46%
1/219 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/222
|
0.91%
2/219 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
Musculoskeletal and connective tissue disorders
PSORIATIC ARTHROPATHY
|
0.00%
0/222
|
0.46%
1/219 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM MALIGNANT
|
0.00%
0/222
|
0.46%
1/219 • Number of events 1
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/222
|
0.46%
1/219 • Number of events 1
|
|
Nervous system disorders
SYNCOPE
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
Psychiatric disorders
ALCOHOL ABUSE
|
0.00%
0/222
|
0.46%
1/219 • Number of events 1
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.00%
0/222
|
0.46%
1/219 • Number of events 1
|
|
Renal and urinary disorders
ACUTE PRERENAL FAILURE
|
0.00%
0/222
|
0.46%
1/219 • Number of events 1
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/222
|
0.46%
1/219 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
ANGIOEDEMA
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.45%
1/222 • Number of events 1
|
0.46%
1/219 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
PUSTULAR PSORIASIS
|
0.45%
1/222 • Number of events 1
|
0.00%
0/219
|
Other adverse events
| Measure |
Maintenance Infliximab
n=222 participants at risk
|
Intermittent Infliximab
n=219 participants at risk
|
|---|---|---|
|
General disorders
INFUSION RELATED REACTION
|
9.0%
20/222 • Number of events 43
|
11.4%
25/219 • Number of events 49
|
|
Infections and infestations
NASOPHARYNGITIS
|
20.7%
46/222 • Number of events 67
|
21.9%
48/219 • Number of events 64
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
9.9%
22/222 • Number of events 33
|
13.7%
30/219 • Number of events 40
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
4.5%
10/222 • Number of events 15
|
5.0%
11/219 • Number of events 14
|
|
Nervous system disorders
HEADACHE
|
6.3%
14/222 • Number of events 24
|
10.5%
23/219 • Number of events 41
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharpe & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to release and can embargo communications regarding trial results for a period that is less than or equal to 45 days from the time submitted to the sponsor for review. If the parties disagree on the communication, the investigator and sponsor's representative will meet for the purpose of making a good faith effort to discuss and resolve any such issues or disagreement.
- Publication restrictions are in place
Restriction type: OTHER