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The Effects of Infliximab Versus Methotrexate in the Treatment of Moderate to Severe Psoriasis (Study P04271AM2)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00251641
Recruitment Status : Completed
First Posted : November 10, 2005
Results First Posted : July 14, 2009
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: infliximab
Drug: methotrexate
Enrollment 868
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Infliximab Methotrexate
Hide Arm/Group Description The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22. Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
Period Title: Overall Study
Started 653 215
Completed 541 127
Not Completed 112 88
Reason Not Completed
Adverse Event             80             8
Lack of Efficacy             2             1
Progression of Disease             0             2
Lost to Follow-up             3             3
Withdrawal by Subject             6             8
Protocol Violation             10             2
Did not Meet protocol Eligibility             2             1
Switched Treatment             9             63
Arm/Group Title Infliximab Methotrexate Total
Hide Arm/Group Description The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22. Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks. Total of all reporting groups
Overall Number of Baseline Participants 653 215 868
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 653 participants 215 participants 868 participants
44.1
(18 to 78)
41.9
(18 to 69)
43.6
(18 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 653 participants 215 participants 868 participants
Female
215
  32.9%
67
  31.2%
282
  32.5%
Male
438
  67.1%
148
  68.8%
586
  67.5%
1.Primary Outcome
Title Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16.
Hide Description PASI75 response is defined as the proportion of participants who achieved at least a 75% improvement in PASI score from Baseline.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were randomized were included in the efficacy analysis (intent-to-treat [ITT]).
Arm/Group Title Infliximab Methotrexate
Hide Arm/Group Description:
The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
Overall Number of Participants Analyzed 653 215
Measure Type: Number
Unit of Measure: Proportion of participants
0.78 0.42
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Infliximab, Methotrexate
Comments The treatment comparison for this endpoint was carried at the 4.9% level of significance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments Pearson's chi-square test
2.Secondary Outcome
Title PASI75 Response at Week 26
Hide Description PASI75 response is defined as the proportion of participants who achieved at least a 75% improvement in PASI score from Baseline.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Infliximab Methotrexate
Hide Arm/Group Description:
The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
Overall Number of Participants Analyzed 653 215
Measure Type: Number
Unit of Measure: Proportion of participants
0.77 0.31
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Infliximab, Methotrexate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Multiplicity adjustment was provided using Hochberg test.
Method Chi-squared
Comments Pearson's chi-square test
3.Secondary Outcome
Title Proportion of Participants Who Achieved a Physician's Global Assessment (PGA) Score of Cleared or Minimal at Week 16
Hide Description PGA is assessed relative to baseline condition and is defined as: clear (100% clear; some residual pinkness or pigmentation: Wornoff's ring may be present), excellent/minimal (75-99% clearing; marked improvement: nearly normal skin texture; some erythema may be present), good (50-74% clearing; moderate improvement: plaque has cleared to point of small scattered papules with normal intervening epidermis), fair (25-49% clearing; slight improvement: decrease in scaling and softening of plaque), poor (0-24% clearing; little or no change in scaling, erythema, or plaque elevation), or worse (worse).
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Infliximab Methotrexate
Hide Arm/Group Description:
The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
Overall Number of Participants Analyzed 653 215
Measure Type: Number
Unit of Measure: Proportion of participants
0.76 0.38
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Infliximab, Methotrexate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Multiplicity adjustment was provided using the Hochberg test.
Method Chi-squared
Comments Pearson's chi-square test
4.Secondary Outcome
Title Proportion of Participants Who Achieved a PGA Score of Cleared or Minimal at Week 26
Hide Description PGA is assessed relative to baseline condition and is defined as: clear (100% clear; some residual pinkness or pigmentation: Wornoff's ring may be present), excellent/minimal (75-99% clearing; marked improvement: nearly normal skin texture; some erythema may be present), good (50-74% clearing; moderate improvement: plaque has cleared to point of small scattered papules with normal intervening epidermis), fair (25-49% clearing; slight improvement: decrease in scaling and softening of plaque), poor (0-24% clearing; little or no change in scaling, erythema, or plaque elevation), or worse (worse).
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Infliximab Methotrexate
Hide Arm/Group Description:
The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
Overall Number of Participants Analyzed 653 215
Measure Type: Number
Unit of Measure: Proportion of participants
0.73 0.28
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Infliximab, Methotrexate
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Multiplicity adjustment was provided using the Hochberg test.
Method Chi-squared
Comments Pearson's chi-square test
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Infliximab Methotrexate Participants Who Switched From Infliximab to Methotrexate Participants Who Switched From Methotrexate to Infliximab
Hide Arm/Group Description Adverse events reported through Week 26 for participants who did not switch treatment at Week 16 and adverse reported through Week 16 for those participants who switched treatment. Adverse events reported through Week 26 for participants who did not switch treatment at Week 16 and adverse reported through Week 16 for those participants who switched treatment. Adverse events reported for participants who switched from infliximab to methotrexate at Week 16 (including only adverse events with begin dates on or after a switch in treatment). Adverse events reported for participants who switched from methotrexate to infliximab at Week 16 (including only adverse events with begin dates on or after a switch in treatment).
All-Cause Mortality
Infliximab Methotrexate Participants Who Switched From Infliximab to Methotrexate Participants Who Switched From Methotrexate to Infliximab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Infliximab Methotrexate Participants Who Switched From Infliximab to Methotrexate Participants Who Switched From Methotrexate to Infliximab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   44/649 (6.78%)      6/211 (2.84%)      0/9 (0.00%)      3/63 (4.76%)    
Blood and lymphatic system disorders         
THROMBOCYTOPENIA  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
Cardiac disorders         
ANGINA PECTORIS  1  1/649 (0.15%)  1 1/211 (0.47%)  1 0/9 (0.00%)  0 0/63 (0.00%)  0
ATRIAL FIBRILLATION  1  2/649 (0.31%)  2 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
MYOCARDIAL INFARCTION  1  0/649 (0.00%)  0 1/211 (0.47%)  1 0/9 (0.00%)  0 0/63 (0.00%)  0
PERICARDITIS  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
Congenital, familial and genetic disorders         
PHIMOSIS  1  0/649 (0.00%)  0 1/211 (0.47%)  1 0/9 (0.00%)  0 0/63 (0.00%)  0
Eye disorders         
IRIDOCYCLITIS  1  0/649 (0.00%)  0 1/211 (0.47%)  1 0/9 (0.00%)  0 0/63 (0.00%)  0
MACULAR HOLE  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
Gastrointestinal disorders         
GASTRITIS  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
General disorders         
INFUSION RELATED REACTION  1  8/649 (1.23%)  10 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
OEDEMA PERIPHERAL  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
PYREXIA  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
Hepatobiliary disorders         
AUTOIMMUNE HEPATITIS  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
BILIARY COLIC  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
CHOLECYSTITIS  1  2/649 (0.31%)  2 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
CHOLECYSTITIS ACUTE  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
CHOLELITHIASIS  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
Immune system disorders         
HYPERSENSITIVITY  1  2/649 (0.31%)  3 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
TYPE IV HYPERSENSITIVITY REACTION  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
Infections and infestations         
ARTHRITIS BACTERIAL  1  0/649 (0.00%)  0 0/211 (0.00%)  0 0/9 (0.00%)  0 1/63 (1.59%)  1
FEBRILE INFECTION  1  0/649 (0.00%)  0 1/211 (0.47%)  1 0/9 (0.00%)  0 0/63 (0.00%)  0
LYME DISEASE  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
PHARYNGITIS STREPTOCOCCAL  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
PNEUMONIA  1  2/649 (0.31%)  2 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
PULMONARY TUBERCULOSIS  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
STAPHYLOCOCCAL INFECTION  1  0/649 (0.00%)  0 0/211 (0.00%)  0 0/9 (0.00%)  0 1/63 (1.59%)  1
VIRAL INFECTION  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
Injury, poisoning and procedural complications         
CERVICAL VERTEBRAL FRACTURE  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
FACIAL BONES FRACTURE  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
MENISCUS LESION  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
Investigations         
HEPATIC ENZYME INCREASED  1  2/649 (0.31%)  2 1/211 (0.47%)  1 0/9 (0.00%)  0 0/63 (0.00%)  0
Metabolism and nutrition disorders         
DIABETES MELLITUS  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
Musculoskeletal and connective tissue disorders         
ARTHRALGIA  1  3/649 (0.46%)  3 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
ARTHRITIS  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
LUPUS-LIKE SYNDROME  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
MYALGIA  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
PAIN IN EXTREMITY  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
PSORIATIC ARTHROPATHY  1  0/649 (0.00%)  0 0/211 (0.00%)  0 0/9 (0.00%)  0 1/63 (1.59%)  1
SPINAL COLUMN STENOSIS  1  0/649 (0.00%)  0 1/211 (0.47%)  1 0/9 (0.00%)  0 0/63 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
FOCAL NODULAR HYPERPLASIA  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
TESTICULAR NEOPLASM  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
Nervous system disorders         
DYSAESTHESIA  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
HYPOAESTHESIA  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
NEUROPATHY PERIPHERAL  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
PARAESTHESIA  1  0/649 (0.00%)  0 1/211 (0.47%)  1 0/9 (0.00%)  0 0/63 (0.00%)  0
SYNCOPE  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
Renal and urinary disorders         
NEPHROLITHIASIS  1  0/649 (0.00%)  0 1/211 (0.47%)  1 0/9 (0.00%)  0 0/63 (0.00%)  0
NOCTURIA  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
Reproductive system and breast disorders         
OVARIAN HAEMORRHAGE  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
DYSPNOEA  1  1/649 (0.15%)  1 1/211 (0.47%)  1 0/9 (0.00%)  0 0/63 (0.00%)  0
INTERSTITIAL LUNG DISEASE  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
PLEURISY  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
PRODUCTIVE COUGH  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
PULMONARY EMBOLISM  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
RESPIRATORY FAILURE  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
Skin and subcutaneous tissue disorders         
NIGHT SWEATS  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
PSORIASIS  1  2/649 (0.31%)  2 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
Vascular disorders         
HYPERTENSION  1  0/649 (0.00%)  0 0/211 (0.00%)  0 0/9 (0.00%)  0 1/63 (1.59%)  1
THROMBOSIS  1  1/649 (0.15%)  1 0/211 (0.00%)  0 0/9 (0.00%)  0 0/63 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Infliximab Methotrexate Participants Who Switched From Infliximab to Methotrexate Participants Who Switched From Methotrexate to Infliximab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   275/649 (42.37%)      95/211 (45.02%)      1/9 (11.11%)      11/63 (17.46%)    
Gastrointestinal disorders         
ABDOMINAL PAIN UPPER  1  7/649 (1.08%)  9 11/211 (5.21%)  27 0/9 (0.00%)  0 0/63 (0.00%)  0
DIARRHOEA  1  21/649 (3.24%)  22 17/211 (8.06%)  34 0/9 (0.00%)  0 1/63 (1.59%)  1
NAUSEA  1  21/649 (3.24%)  30 20/211 (9.48%)  77 0/9 (0.00%)  0 0/63 (0.00%)  0
General disorders         
FATIGUE  1  26/649 (4.01%)  28 19/211 (9.00%)  39 0/9 (0.00%)  0 0/63 (0.00%)  0
INFUSION RELATED REACTION  1  70/649 (10.79%)  139 0/211 (0.00%)  0 0/9 (0.00%)  0 5/63 (7.94%)  10
Infections and infestations         
NASOPHARYNGITIS  1  119/649 (18.34%)  157 40/211 (18.96%)  46 0/9 (0.00%)  0 3/63 (4.76%)  3
Musculoskeletal and connective tissue disorders         
ARTHRALGIA  1  41/649 (6.32%)  54 12/211 (5.69%)  15 0/9 (0.00%)  0 0/63 (0.00%)  0
Nervous system disorders         
HEADACHE  1  66/649 (10.17%)  111 31/211 (14.69%)  74 0/9 (0.00%)  0 5/63 (7.94%)  7
Reproductive system and breast disorders         
EPIDIDYMITIS  1  1/649 (0.15%)  1 0/211 (0.00%)  0 1/9 (11.11%)  1 0/63 (0.00%)  0
Skin and subcutaneous tissue disorders         
PRURITUS  1  39/649 (6.01%)  50 4/211 (1.90%)  4 0/9 (0.00%)  0 1/63 (1.59%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI must provide sponsor w/ review copies of abstracts or manuscripts for publication that report any results of the study, 45 days before submission for publication or presentation. The sponsor shall have the right to review/comment on the material. If the parties disagree about the appropriateness of the material, PI must meet with sponsor's representatives before submission for publication, for the purpose of making good faith efforts to discuss and resolve any issues of disagreement.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00251641     History of Changes
Other Study ID Numbers: P04271
First Submitted: November 8, 2005
First Posted: November 10, 2005
Results First Submitted: May 21, 2009
Results First Posted: July 14, 2009
Last Update Posted: May 10, 2017