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An Efficacy and Safety of CNTO 1959 (Guselkumab) in Participants With Moderate to Severe Plaque-type Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02325219
Recruitment Status : Completed
First Posted : December 24, 2014
Results First Posted : May 14, 2020
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Brief Summary:
The purpose of this study is to demonstrate the superiority of CNTO 1959 (guselkumab) to placebo in the treatment of participants with moderate to severe plaque-type psoriasis (A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches).

Condition or disease Intervention/treatment Phase
Psoriasis Drug: CNTO 1959 50 mg Drug: CTNO 1959 100 mg Drug: Placebo 50 mg Drug: Placebo 100 mg Phase 3

Detailed Description:
A Phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participant know about the study treatment), placebo-controlled (a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect) study of CNTO 1959 (Guselkumab) in the treatment of participants with moderate to severe plaque-type psoriasis. Participants will receive either treatment of CNTO 1959 (guselkumab) 50 milligram (mg) or 100 mg or Placebo 50 mg or 100 mg. Participants will primarily be assessed for Investigator's Global Assessment (IGA) Score and Psoriasis Area and Severity Index (PASI). Participants' safety will be monitored throughout the study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of CNTO 1959 (Guselkumab) in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis
Actual Study Start Date : December 19, 2014
Actual Primary Completion Date : March 2, 2016
Actual Study Completion Date : February 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Guselkumab

Arm Intervention/treatment
Experimental: Group 1
Participants will receive subcutaneous injection of CNTO 1959 50 milligram (mg) and placebo 100 mg at Week 0, 4 and then every 8 weeks thereafter.
Drug: CNTO 1959 50 mg
Participants will receive subcutaneous injection of CNTO 1959 50 mg.
Other Name: Guselkumab

Drug: Placebo 100 mg
Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 100 mg.

Experimental: Group 2
Participants will receive subcutaneous injection of CNTO 1959 100 milligram (mg) and placebo 50 mg at Week 0, 4 and then every 8 weeks thereafter.
Drug: CTNO 1959 100 mg
Participants will receive subcutaneous injection of CNTO 1959 100 mg.
Other Name: Guselkumab

Drug: Placebo 50 mg
Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 50 mg.

Experimental: Group 3
Participants will receive subcutaneous injection of placebo 50 mg and 100 mg at Weeks 0, 4 and 12. At Week 16, participants will be randomized in sub-group 3a to receive either CNTO1959 50 mg and placebo 100 mg at Week 16, 20 and then every 8 weeks thereafter or sub-group 3b to receive CNTO 1959 100 mg and placebo 50 mg at Week 16, 20 and then every 8 weeks thereafter.
Drug: CNTO 1959 50 mg
Participants will receive subcutaneous injection of CNTO 1959 50 mg.
Other Name: Guselkumab

Drug: CTNO 1959 100 mg
Participants will receive subcutaneous injection of CNTO 1959 100 mg.
Other Name: Guselkumab

Drug: Placebo 50 mg
Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 50 mg.

Drug: Placebo 100 mg
Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 100 mg.




Primary Outcome Measures :
  1. Percentage of Participants With an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 [ Time Frame: Week 16 ]
    The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

  2. Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 [ Time Frame: Week 16 ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline.


Secondary Outcome Measures :
  1. Percentage of Participants Who Achieved PASI 75 Response at Week 16 [ Time Frame: Week 16 ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline.

  2. Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 [ Time Frame: Baseline and Week 16 ]
    The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

  3. Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16 [ Time Frame: Weeks 2, 4, 8, 12, and 16 ]
    The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

  4. Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52 [ Time Frame: Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52 ]
    The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

  5. Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16 [ Time Frame: Weeks 2, 4, 8, 12, and 16 ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 50, 75, 90, and 100 responses were defined as at least a 50%, 75%, 90%, and 100% reduction in PASI relative to Baseline respectively.

  6. Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52 [ Time Frame: Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52 ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 50, 75, 90, and 100 responses were defined as at least a 50%, 75%, 90%, and 100% reduction in PASI relative to Baseline respectively.

  7. Percent Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 16 [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16 ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

  8. Percent Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52 [ Time Frame: Baseline and Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52 ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

  9. Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 16 [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16 ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

  10. Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52 [ Time Frame: Baseline and Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52 ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

  11. Change From Baseline in Body Surface Area (BSA) Involvement by Psoriatic Lesions at Week 48 [ Time Frame: Baseline and Week 48 ]
    BSA as physical measure to define disease severity is to determine how much of the Body Surface Area (BSA) is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.

  12. Change From Baseline in Nail Psoriasis Area and Severity Index (NAPSI) Score at Week 16 [ Time Frame: Baseline and Week 16 ]
    NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).

  13. Change From Baseline in NAPSI Score at Weeks 28, 36, 48, 52 [ Time Frame: Baseline and Weeks 28, 36, 48, 52 ]
    NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).

  14. Percent Change From Baseline in NAPSI Score at Week 16 [ Time Frame: Baseline and Week 16 ]
    NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).

  15. Percent Change From Baseline in NAPSI Score at Weeks 28, 36, 48, 52 [ Time Frame: Baseline and Weeks 28, 36, 48, 52 ]
    NAPSI is an index used for assessing and grading the severity of nail psoriasis. A target nail representing the worst nail psoriasis at baseline is divided into quadrants and is graded for nail matrix psoriasis (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed psoriasis (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis), each on a scale of 0 to 4. The sum of these scores is the total NAPSI score. The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).

  16. Percentage of Participants With a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-grade Improvement From Baseline at Week 16 [ Time Frame: Week 16 ]
    The percentage of participants with an ss-IGA score of absence of disease (0) or very mild disease (1) and at least a 2-grade improvement from Baseline at Week 16 among participants who had an ss-IGA score of >= 2 at baseline was evaluated. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).

  17. Percentage of Participants With an Ss-IGA Score of 0 or 1 and at Least a 2-grade Improvement From Baseline at Weeks 28, 48 and 52 [ Time Frame: Week 28, 48 and 52 ]
    The percentage of participants with an ss-IGA score of absence of disease (0) or very mild disease (1) and at least a 2-grade improvement from Baseline at Week 16 among participants who had an ss-IGA score of >= 2 at baseline was evaluated. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).

  18. Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 16 [ Time Frame: Week 16 ]
    The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).

  19. Percentage of Participants Who Achieved Ss-IGA Scores Among Participants With Baseline Ss-IGA Score >=2 at Week 28, 48 and 52 [ Time Frame: Week 28, 48 and 52 ]
    The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: Absence of Disease (0), Very Mild Disease (1), Mild Disease (2), Moderate Disease (3), and Severe Disease (4).

  20. Percentage of Participants With a DLQI Score of 0 or 1 at Weeks 8 and 16 [ Time Frame: Weeks 8 and 16 ]
    The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

  21. Percentage of Participants With a DLQI Score of 0 or 1 at Weeks 28, 36, 48, and 52 [ Time Frame: Weeks 28, 36, 48, and 52 ]
    The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

  22. Change From Baseline in the DLQI Total Score at Week 8 [ Time Frame: Baseline and Weeks 8 ]
    The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

  23. Change From Baseline in the DLQI Total Score at Weeks 28, 36, 48, 52 [ Time Frame: Baseline and Weeks 28, 36, 48, 52 ]
    The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

  24. Percentage of Participants With >=5-point Decrease in the DLQI Total Score From Baseline at Weeks 8 and 16 [ Time Frame: Weeks 8 and 16 ]
    The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

  25. Percentage of Participants With >=5-point Decrease in the DLQI Total Score From Baseline at Weeks 28, 36, 48, and 52 [ Time Frame: Weeks 28, 36, 48, and 52 ]
    The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.

  26. Change From Baseline in EuroQol-5 Dimensions Questionnaire (EQ-5D): Index Score at Week 16 [ Time Frame: Baseline and Week 16 ]
    The EQ-5D is designed for self-completion by participants and consists of 2 pages - the EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and severe problems. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  27. Change From Baseline in EuroQol-5 Dimensions Questionnaire (EQ-5D): Index Score at Weeks 28 and 48 [ Time Frame: Baseline and Weeks 28, 48 ]
    The EQ-5D is designed for self-completion by participants and consists of 2 pages - the EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and severe problems. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  28. Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Week 16 [ Time Frame: Baseline and Week 16 ]
    The EQ visual analog scale (EQ VAS) is the part of EQ-5D scale. The EQ VAS records the respondent's self-rated health on a vertical, visual analog scale where the endpoints are labeled 'Best imaginable health state' (score of 100) and 'Worst imaginable health state' (score of 0).

  29. Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Weeks 28, 48 [ Time Frame: Baseline and Weeks 28, 48 ]
    The EQ visual analog scale (EQ VAS) is the part of EQ-5D scale. The EQ VAS records the respondent's self-rated health on a vertical, visual analog scale where the endpoints are labeled 'Best imaginable health state' (score of 100) and 'Worst imaginable health state' (score of 0).

  30. Change From Baseline in the Physical and Mental Component Summary (PCS and MCS) Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Week 16 [ Time Frame: Baseline and Week 16 ]
    SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. Higher scores indicate better health status.

  31. Change From Baseline in the PCS and MCS Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Weeks 28 and 48 [ Time Frame: Baseline and Weeks 28, 48 ]
    SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: PCS and MCS. The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. Higher scores indicate better health status.

  32. Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Week 16 [ Time Frame: Baseline and Week 16 ]
    Changes from baseline in the 4 types (absenteeism, activity impairment, presenteeism, and Work productivity loss) of WPAI scores at Week 16 were evaluated. The WPAI questionnaire is used to measure productivity loss associated with psoriasis during the past 7 days. It consists of six questions about absence from work because of psoriasis, hours actually worked, reduction in productivity at work attributed to psoriasis and reduction in productivity while performing daily activities. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity.

  33. Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire Scores at Weeks 28 and 48 [ Time Frame: Baseline and Weeks 28, 48 ]
    Changes from baseline in the 4 types (absenteeism, activity impairment, presenteeism, and Work productivity loss) of WPAI scores at Weeks 28 and 48 were evaluated. The WPAI questionnaire is used to measure productivity loss associated with psoriasis during the past 7 days. It consists of six questions about absence from work because of psoriasis, hours actually worked, reduction in productivity at work attributed to psoriasis and reduction in productivity while performing daily activities. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity.

  34. Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, and ACR 70 Responses at Weeks 4, 8, and 16 [ Time Frame: Weeks 4, 8, and 16 ]
    ACR Response is defined as percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in swollen joint (66 joints) and tender joint (68 joints) counts and percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in 3 of following 5 assessments: patient's assessment of pain using VAS (VAS; 0-10, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity by using VAS (scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas;derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).

  35. Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 28, 36, 48, and 52 [ Time Frame: Weeks 28, 36, 48, and 52 ]
    ACR Response is defined as percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in swollen joint (66 joints) and tender joint (68 joints) counts and percent improvement from baseline of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) in 3 of following 5 assessments: patient's assessment of pain using VAS (VAS; 0-10, 0=no pain and 10=worst possible pain), patient's global assessment of disease activity by using VAS (scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas;derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).

  36. Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16 [ Time Frame: Weeks 4, 8, and 16 ]
    Percent change from baseline in the tender joints and swollen joints counts at Weeks 4, 8, and 16 was evaluated.

  37. Percent Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52 [ Time Frame: Weeks 28, 36, 48, and 52 ]
    Percent change from baseline in the tender joints and swollen joints counts at Weeks 28, 36, 48 and 52 was evaluated.

  38. Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 4, 8, and 16 [ Time Frame: Baseline and Weeks 4, 8, 16 ]
    Change from baseline in the tender joints and swollen joints counts at Weeks 4, 8, and 16 was evaluated.

  39. Change From Baseline in the Tender Joints Count and Swollen Joints Count at Weeks 28, 36, 48, and 52 [ Time Frame: Baseline and Weeks 28, 36, 48, 52 ]
    Change from baseline in the tender joints and swollen joints counts at Weeks 28, 36, 48 and 52 was evaluated.

  40. Percent Change From Baseline in Patient's Assessment of Pain (VAS) at Weeks 4, 8, 16 [ Time Frame: Baseline and Weeks 4, 8, 16 ]
    Percent change from baseline in Patient's Assessment of Pain (VAS) among participants who had a diagnosis of PsA at screening at Weeks 4, 8 and 16 was evaluated. Each participant assessed his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 millimeter (mm) (no pain) to 100 mm (the worst pain imaginable).

  41. Percent Change From Baseline in Patient's Assessment of Pain (VAS) at Weeks 28, 36, 48, 52 [ Time Frame: Baseline and Weeks 28, 36, 48, 52 ]
    Percent change from baseline in Patient's Assessment of Pain (VAS) among participants who had a diagnosis of PsA at screening at Weeks 28, 36, 48 and 52 was evaluated. Each participant assessed his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 mm (no pain) to 100 mm (the worst pain imaginable).

  42. Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 4, 8, 16 [ Time Frame: Baseline and Weeks 4, 8, 16 ]
    The participant's and physician's global assessments of disease activity were recorded on a VAS. The VAS for the participant's assessment ranges from "very well" (0 centimeter [cm]) to "very poor" (10 cm).

  43. Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 28, 36, 48, and 52 [ Time Frame: Baseline and Weeks 28, 36, 48, 52 ]
    The participant's and physician's global assessments of disease activity were recorded on a VAS. The VAS for the participant's assessment ranges from "very well" (0 cm) to "very poor" (10 cm).

  44. Percentage of Participants Who Achieved Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Weeks 4, 8 and 16 [ Time Frame: Weeks 4, 8, and 16 ]
    HAQ-DI response was defined as change of less than or equal to (<=) -0.3 from baseline in HAQ-DI score. HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area (that is, lower scores are indicative of better functioning).

  45. Percentage of Participants Who Achieved HAQ-DI Response at Weeks 28, 36, 48, 52 [ Time Frame: Weeks 28, 36, 48, 52 ]
    HAQ-DI response was defined as change of less than or equal to (<=) -0.3 from baseline in HAQ-DI score. HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area (that is, lower scores are indicative of better functioning).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months before Screening
  • Have a PASI greater than or equal to (>=) 12 at Screening and at Baseline
  • Have an IGA >= 3 at Screening and at Baseline
  • Have an involved body surface area (BSA) >=10 percent (%) at Screening and at Baseline
  • Be a candidate for phototherapy or systemic treatment for psoriasis (either naive or history of previous treatment)

Exclusion Criteria:

  • Has a history of or current signs or symptoms of severe, progressive, or uncontrolled cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances
  • Has unstable cardiovascular disease, defined as a recent clinical deterioration (example, unstable angina, atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months before Screening
  • Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before Screening
  • Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly
  • Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02325219


Locations
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Japan
Asahikawa, Japan
Chuo, Japan
Gifu, Japan
Isehara-city,, Japan
Izumo, Japan
Kanazawa, Japan
Kawasaki, Japan
Kita-Gun, Japan
Kochi, Japan
Kurume, Japan
Kyoto, Japan
Matsumoto, Japan
Miyagi, Japan
Morioka, Japan
Nagoya, Japan
Osaka-Sayama, Japan
Osaka, Japan
Sapporo, Japan
Shimotsuke, Japan
Shinjuku-ku, Japan
Tokushima, Japan
Tokyo, Japan
Toon, Japan
Tsukuba, Japan
Tsu, Japan
Ube, Japan
Yokosuka, Japan
Sponsors and Collaborators
Janssen Pharmaceutical K.K.

Additional Information:
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Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT02325219    
Other Study ID Numbers: CR103833
CNTO1959PSO3004 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Posted: December 24, 2014    Key Record Dates
Results First Posted: May 14, 2020
Last Update Posted: May 22, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Pharmaceutical K.K.:
Psoriasis
CNTO 1959
Guselkumab
Placebo
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs