Trial Outcomes & Findings for A Study to Evaluate the Switch From Etanercept to Infliximab in Subjects With Moderate-to-Severe Psoriasis (Study P05133) (NCT NCT00686595)

NCT ID: NCT00686595

Last Updated: 2023-08-09

Results Overview

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 75 response rate at Week 10 is measured as the percentage of participants who achieved at least 75% improvement from baseline PASI at Week 10.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 48 participants
• Primary outcome timeframe: Baseline and 10 weeks
• Results posted on: 2023-08-09

Participant Flow

48 participants were enrolled in this study. Of these, 38 participants received at least one dose of the study medication and represent the intent-to-treat (ITT) population.

Participant milestones

Measure	Infliximab 5 mg/kg Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Study STARTED	38
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Infliximab 5 mg/kg Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Overall Study Adverse Event	3
Overall Study Protocol Violation	1
Overall Study Lost to Follow-up	1
Overall Study Lack of Efficacy	1
Overall Study Poor Compliance	1

Baseline Characteristics

A Study to Evaluate the Switch From Etanercept to Infliximab in Subjects With Moderate-to-Severe Psoriasis (Study P05133)

Baseline characteristics by cohort

Measure	Infliximab 5 mg/kg n=38 Participants Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Age, Continuous	46.54 years STANDARD_DEVIATION 9.70 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 10 weeks

Population: Participants from the intent-to-treat (ITT) population for whom the PASI assessment was available.

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 75 response rate at Week 10 is measured as the percentage of participants who achieved at least 75% improvement from baseline PASI at Week 10.

Outcome measures

Measure	Infliximab 5 mg/kg n=35 Participants Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Psoriasis Area and Severity Index (PASI) 75 Response Rate at Week 10	71 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and 18 weeks

Population: Participants from the ITT population for whom the PASI assessment was available.

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 75 response rate at Week 18 is measured as the percentage of participants who achieved at least 75% improvement from baseline PASI at Week 18.

Outcome measures

Measure	Infliximab 5 mg/kg n=32 Participants Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
PASI 75 Response Rate at Week 18	94 Percent of participants

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: Participants from the ITT population for whom the PASI assessment was available.

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 75 response rate at Week 24 is measured as the percentage of participants who achieved at least 75% improvement from baseline PASI at Week 24.

Outcome measures

Measure	Infliximab 5 mg/kg n=35 Participants Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
PASI 75 Response Rate at Week 24	74 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and 10 weeks

Population: Participants from the ITT population for whom the PASI assessment was available.

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 50 response rate at Week 10 is measured as the percentage of participants who achieved at least 50% improvement from baseline PASI at Week 10.

Outcome measures

Measure	Infliximab 5 mg/kg n=35 Participants Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
PASI 50 Response Rate at Week 10	91 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and 18 weeks

Population: Participants from the ITT population for whom the PASI assessment was available.

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 50 response rate at Week 18 is measured as the percentage of participants who achieved at least 50% improvement from baseline PASI at Week 18.

Outcome measures

Measure	Infliximab 5 mg/kg n=32 Participants Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
PASI 50 Response Rate at Week 18	97 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: Participants from the ITT population for whom the PASI assessment was available.

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 50 response rate at Week 24 is measured as the percentage of participants who achieved at least 50% improvement from baseline PASI at Week 24.

Outcome measures

Measure	Infliximab 5 mg/kg n=35 Participants Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
PASI 50 Response Rate at Week 24	89 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and 10 weeks

Population: Participants from the ITT population for whom the PASI assessment was available.

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 90 response rate at Week 10 is measured as the percentage of participants who achieved at least 90% improvement from baseline PASI at Week 10.

Outcome measures

Measure	Infliximab 5 mg/kg n=35 Participants Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
PASI 90 Response Rate at Week 10	37 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and 18 weeks

Population: Participants from the ITT population for whom the PASI assessment was available.

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 90 response rate at Week 18 is measured as the percentage of participants who achieved at least 90% improvement from baseline PASI at Week 18.

Outcome measures

Measure	Infliximab 5 mg/kg n=32 Participants Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
PASI 90 Response Rate at Week 18	56 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: Participants from the ITT population for whom the PASI assessment was available.

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 90 response rate at Week 24 is measured as the percentage of participants who achieved at least 90% improvement from baseline PASI at Week 24.in PASI at Week 24

Outcome measures

Measure	Infliximab 5 mg/kg n=35 Participants Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
PASI 90 Response Rate at Week 24	54 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and 10 weeks

Population: Participants from the ITT population for whom the PASI assessment was available.

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 10 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 10.

Outcome measures

Measure	Infliximab 5 mg/kg n=35 Participants Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
PASI 100 Response Rate at Week 10	17 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and 18 weeks

Population: Participants from the ITT population for whom the PASI assessment was available.

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 18 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 18.

Outcome measures

Measure	Infliximab 5 mg/kg n=32 Participants Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
PASI 100 Response Rate at Week 18	31 Percentage of participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Participants from the ITT population for whom the PASI assessment was available.

PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72. The PASI 100 response rate at Week 24 is measured as the percentage of participants who achieved 100% improvement from baseline PASI at Week 24.

Outcome measures

Measure	Infliximab 5 mg/kg n=35 Participants Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
PASI 100 Response Rate at Week 24	40 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: Participants from the ITT population for whom the SAPASI assessment was available.

SAPASI is the participant's measurement of severity of psoriasis. The participant estimates the area of psoriatic involvement for each body district (head, upper limbs, trunk and lower limbs) and scores it from 0 (no involvement)-6 (90-100% involvement); and the extent of psoriasis from 0 (no involvement) to 4 (very marked) for each - erythema, desquamation and induration of the plaques. The final score computed by the investigator ranged from 0-72. The percent reduction in SAPASI at Week 18 compared to baseline is reported.

Outcome measures

Measure	Infliximab 5 mg/kg n=31 Participants Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Percent Reduction in Self-Administered Psoriasis Area Severity Index (SAPASI) at Week 18	89 Percent reduction Standard Deviation 15

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Participants from the ITT population for whom the SAPASI assessment was available.

SAPASI is the participant's measurement of severity of psoriasis. The participant estimates the area of psoriatic involvement for each body district (head, upper limbs, trunk and lower limbs) and scores it from 0 (no involvement)-6 (90-100% involvement); and the extent of psoriasis from 0 (no involvement) to 4 (very marked) for each - erythema, desquamation and induration of the plaques. The final score computed by the investigator ranged from 0-72. The percent reduction in SAPASI at Week 24 compared to baseline is reported.

Outcome measures

Measure	Infliximab 5 mg/kg n=33 Participants Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Percent Reduction in SAPASI at Week 24	82 Percent reduction Standard Deviation 29

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: Participants from the ITT population for whom the BSA assessment was available.

The BSA is the physician's evaluation for the extent of disease. The entire body area is divided into 4 districts: head, upper limbs, trunk and lower limbs to which corresponds the 10%, 20%, 30% and 40% of the entire body surface respectively. The investigator assesses the percentage of the participant's body surface area affected by psoriasis in each district. The final affected BSA value is the sum of the percentage of each district. The percent reduction in affected BSA at Week 18 compared to baseline is reported.

Outcome measures

Measure	Infliximab 5 mg/kg n=32 Participants Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Percent Reduction in Affected Body Surface Area (BSA) at Week 18	82 Percent reduction Standard Deviation 28

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Participants from the ITT population for whom the BSA assessment was available.

The BSA is the physician's evaluation for the extent of disease. The entire body area is divided into 4 districts: head, upper limbs, trunk and lower limbs to which corresponds the 10%, 20%, 30% and 40% of the entire body surface respectively. The investigator assesses the percentage of the participant's body surface area affected by psoriasis in each district. The final affected BSA value is the sum of the percentage of each district. The percent reduction in affected BSA at Week 24 compared to baseline is reported.

Outcome measures

Measure	Infliximab 5 mg/kg n=35 Participants Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Percent Reduction in Affected BSA at Week 24	72 Percent reduction Standard Deviation 39

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: Participants from the ITT population for whom the VAS assessment was available.

VAS was used to measure itch. Participants reported itch using VAS - a line ranging from 0 cm to 10 cm, measured by the investigator. 0 cm referred to absence of itch and 10 cm referred to severe itching. The percent reduction in VAS at Week 18 compared to baseline is reported.

Outcome measures

Measure	Infliximab 5 mg/kg n=30 Participants Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Percent Reduction in Visual Analogue Scale (VAS) Referred Itch at Week 18	81 Percent reduction Standard Deviation 27

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Participants from the ITT population for whom the VAS assessment was available.

VAS was used to measure itch. Participants reported itch using VAS - a line ranging from 0 cm to 10 cm, measured by the investigator. 0 cm referred to absence of itch and 10 cm referred to severe itching. The percent reduction in VAS at Week 24 compared to baseline is reported.

Outcome measures

Measure	Infliximab 5 mg/kg n=33 Participants Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Percent Reduction in VAS Referred Itch at Week 24	72 Percent reduction Standard Deviation 38

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: Participants from the ITT population for whom the DLQI assessment was available.

DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst. The percent reduction in DLQI score at Week 18 compared to baseline is reported.

Outcome measures

Measure	Infliximab 5 mg/kg n=30 Participants Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Percent Reduction in Dermatology Life Quality Index (DLQI) Total Score at Week 18	77 Percent reduction Standard Deviation 35

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Participants from the ITT population for whom the DLQI assessment was available.

DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst. The percent reduction in DLQI score at Week 24 compared to baseline is reported.

Outcome measures

Measure	Infliximab 5 mg/kg n=31 Participants Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Percent Reduction in DLQI Total Score at Week 24	68 Percent reduction Standard Deviation 50

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: Participants from the ITT population for whom the SKINDEX-29 assessments were available.

The SKINDEX-29 measures the quality of life in dermatological participants, who complete a questionnaire assessing 3 scales - burden of symptoms, social functioning and emotional state. Participants answered 29 questions referring to the previous 4-week period, on a 5-point scale from "never" (=0) to "all the time" (=4). The score for each scale ranges from 0 to 100 and higher scores reflect a worse quality of life. The percent reduction in SKINDEX-29 scores at Week 18 compared to baseline is reported.

Outcome measures

Measure	Infliximab 5 mg/kg n=31 Participants Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Percent Reduction in Skin Index Questionnaire (SKINDEX-29) Score at Week 18 Symptoms score	42 Percent reduction Standard Deviation 26
Percent Reduction in Skin Index Questionnaire (SKINDEX-29) Score at Week 18 Emotional state score	39 Percent reduction Standard Deviation 25
Percent Reduction in Skin Index Questionnaire (SKINDEX-29) Score at Week 18 Social functioning score	39 Percent reduction Standard Deviation 27

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Participants from the ITT population for whom the SKINDEX-29 assessments were available.

The SKINDEX-29 measures the quality of life in dermatological participants, who complete a questionnaire assessing 3 scales - burden of symptoms, social functioning and emotional state. Participants answered 29 questions referring to the previous 4-week period, on a 5-point scale from "never" (=0) to "all the time" (=4). The score for each scale ranges from 0 to 100 and higher scores reflect a worse quality of life. The percent reduction in SKINDEX-29 scores at Week 24 compared to baseline is reported.

Outcome measures

Measure	Infliximab 5 mg/kg n=34 Participants Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Percent Reduction in SKINDEX-29 Scores at Week 24 Symptoms score	40 Percent reduction Standard Deviation 29
Percent Reduction in SKINDEX-29 Scores at Week 24 Emotional state score	32 Percent reduction Standard Deviation 34
Percent Reduction in SKINDEX-29 Scores at Week 24 Social functioning score	31 Percent reduction Standard Deviation 36

Adverse Events

Infliximab 5 mg/kg

Serious events: 7 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Infliximab 5 mg/kg n=38 participants at risk Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Cardiac disorders Mitral Valve Prolapse	2.6% 1/38 • Number of events 1
General disorders Cyst	2.6% 1/38 • Number of events 1
General disorders Electrocution	2.6% 1/38 • Number of events 1
Injury, poisoning and procedural complications Overdose	7.9% 3/38 • Number of events 4
Psychiatric disorders Completed Suicide	2.6% 1/38 • Number of events 1

Other adverse events

Measure	Infliximab 5 mg/kg n=38 participants at risk Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).
Gastrointestinal disorders Gastritis	5.3% 2/38 • Number of events 2
Infections and infestations Bronchitis	5.3% 2/38 • Number of events 2
Infections and infestations Rhinitis	7.9% 3/38 • Number of events 3
Investigations Blood Triglycerides Increased	5.3% 2/38 • Number of events 2
Investigations Transaminases Increased	5.3% 2/38 • Number of events 2
Nervous system disorders Dizziness	5.3% 2/38 • Number of events 2
Skin and subcutaneous tissue disorders Pruritus	10.5% 4/38 • Number of events 11

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharpe & Dohme Corp

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee Investigator agrees not to publish or publicly present any of the study results without prior written authorization from sponsor, except than for the dispositions provided in the Minister's Decree and Ministerial Circular. Investigator agrees to provide 45 days written notice to sponsor prior to submission for publication or presentation to permit sponsor to review copies of abstracts/manuscripts for publication (including text for oral presentations) which report any study results.
• Publication restrictions are in place

Restriction type: OTHER