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A Study to Evaluate the Safety and Efficacy of Adalimumab in Subjects With Chronic Plaque Psoriasis and Nail 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: NCT02016482
Recruitment Status : Completed
First Posted : December 20, 2013
Results First Posted : February 13, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE December 16, 2013
First Posted Date  ICMJE December 20, 2013
Results First Submitted Date  ICMJE October 21, 2016
Results First Posted Date  ICMJE February 13, 2017
Last Update Posted Date May 30, 2017
Study Start Date  ICMJE January 2014
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2016)
  • Percentage of Participants Achieving a Total Fingernail Modified Nail Psoriasis Severity Index (mNAPSI) 75 Response at Week 26 [ Time Frame: Week 26 ]
    Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. Investigators assessed each nail abnormality for each of a participant's nails by grading 3 features or groups of features (pitting, onycholysis and oil-drop dyschromia, and crumbling) and noting the presence or absence of 4 features (leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in the lunula). The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement. The mNAPSI 75 response is defined as at least 75% reduction from baseline in mNAPSI.
  • For United States (US) Regulatory Purposes: Percentage of Participants With a Physician's Global Assessment of Fingernails (PGA-F) of "Clear" or "Minimal" at Week 26 [ Time Frame: Week 26 ]
    The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe, was separately assigned for nail bed involvement and nail matrix involvement. A participant's overall global score was the worse of the nail bed and nail matrix score. Data presents the percentage of participants with a PGA-F overall global score that met the definition of "clear" (0) or "minimal" (1) with at least a 2-grade improvement relative to Baseline at Week 26.
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
  • Proportion of subjects achieving a total-fingernail modified Nail Psoriasis Severity Index (mNAPSI) 75 response [ Time Frame: At Week 26 ]
    Subjects achieving a 75% reduction in total mNAPSI of all fingernails
  • Proportion of subjects with a Physician's Global Assessment of Fingernails of "clear" or "minimal" [ Time Frame: At Week 26 ]
    Physician's assessment of patient's fingernails that meet definition of clear or minimal.
Change History Complete list of historical versions of study NCT02016482 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2016)
  • Percent Change From Baseline in Total Fingernail Nail Psoriasis Severity Index (NAPSI) Score at Week 26 [ Time Frame: Baseline, Week 26 ]
    Each fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 80, with a score of 0 indicating absence of nail psoriasis and 80 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.
  • Percentage of Participants Achieving Total Fingernail mNAPSI Score of 0 at Week 26 [ Time Frame: Week 26 ]
    Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
  • Percent Change From Baseline in Nail Psoriasis Pain Numeric Rating Scale (NRS) at Week 26 [ Time Frame: Baseline, Week 26 ]
    An NRS was used to capture a participant's self-reporting of her/his worst fingernail pain and average fingernail pain due to fingernail psoriasis. The participant rated the severity of fingernail pain over the past 7 days on a scale from 0 indicating no pain, to 10 indicating severe pain. A negative change from Baseline indicates improvement.
  • Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26 [ Time Frame: Baseline, Week 26 ]
    Participants were asked to rate the impact of their fingernail psoriasis on their ability to perform physical tasks (eg, typing, housework, buttoning a shirt or blouse, picking up coins from a table, tying shoes, yard work, etc.) over the past 7 days on a scale of 0 indicating no impact on ability to perform physical tasks, to 10 indicating severe impact on ability to perform physical tasks. A negative change from Baseline indicates improvement.
  • Percentage of Participants With at Least 50% Improvement in the Scalp Component of the Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index (B-SNIPI) at Week 26 [ Time Frame: Baseline, Week 26 ]
    The range of possible scores was 0 to 20 for scalp psoriasis, with a score of 0 indicating absence of psoriasis. A decrease in B-SNIPI score indicates improvement. Data presents the percentage of participants achieving 50% improvement in the scalp component of the B-SNIPI among participants with Baseline scalp score of ≥ 6.
  • Percentage of Participants Achieving "Clear" or "Minimal" in Nail Bed Component of the PGA-F at Week 26 [ Time Frame: Week 26 ]
    The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe, was separately assigned for nail bed involvement and nail matrix involvement. A participant's overall global score was the worse of the nail bed and nail matrix score. Data presents the percentage of participants with a nail bed component of the PGA-F that met definition of "clear" (0) or "minimal" (1) among those with a Baseline nail bed component of "moderate" or "worse."
  • Percentage of Participants Achieving "Clear" or "Minimal" in Nail Matrix Component of the PGA-F At Week 26 [ Time Frame: Week 26 ]
    The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe, was separately assigned for nail bed involvement and nail matrix involvement. A participant's overall global score was the worse of the nail bed and nail matrix score. Data presents the percentage of participants with a nail matrix component of the PGA-F that met definition of "clear" (0) or "minimal" (1) among those with a Baseline nail matrix component of "moderate" or "worse."
  • Percentage of Participants Achieving Target Fingernail mNAPSI Score of 0 at Week 26 [ Time Frame: Week 26 ]
    The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
  • Percentage of Participants Achieving Target Fingernail mNAPSI Score of ≤ 2 at Week 26 [ Time Frame: Week 26 ]
    The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
  • Percentage of Participants Achieving Total Fingernail mNAPSI Score of ≤ 2 at Week 26 [ Time Frame: Week 26 ]
    Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
  • Change From Baseline in Target Fingernail mNAPSI Score at Week 26 [ Time Frame: Baseline, Week 26 ]
    The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
  • Percent Change From Baseline in Target Fingernail mNAPSI Score at Week 26 [ Time Frame: Baseline, Week 26 ]
    The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
  • Change From Baseline in Total Fingernail mNAPSI Score at Week 26 [ Time Frame: Baseline, Week 26 ]
    Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
  • Percent Change From Baseline in Total Fingernail mNAPSI Score at Week 26 [ Time Frame: Baseline, Week 26 ]
    Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
  • Percentage of Participants Achieving Total Fingernail NAPSI Score of 0 at Week 26 [ Time Frame: Week 26 ]
    Each fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 80, with a score of 0 indicating absence of nail psoriasis and 80 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.
  • Percentage of Participants Achieving Target Fingernail NAPSI Score of 0 at Week 26 [ Time Frame: Week 26 ]
    The target fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI. The range of possible scores was 0 to 8, with a score of 0 indicating absence of nail psoriasis and 8 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.
  • Change From Baseline in Target Fingernail NAPSI Score at Week 26 [ Time Frame: Baseline, Week 26 ]
    The target fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI. The range of possible scores was 0 to 8, with a score of 0 indicating absence of nail psoriasis and 8 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.
  • Percent Change From Baseline in Target Fingernail NAPSI Score at Week 26 [ Time Frame: Baseline, Week 26 ]
    The target fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI. The range of possible scores was 0 to 8, with a score of 0 indicating absence of nail psoriasis and 8 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.
  • Change From Baseline in Total Fingernail NAPSI Score at Week 26 [ Time Frame: Baseline, Week 26 ]
    Each fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 80, with a score of 0 indicating absence of nail psoriasis and 80 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.
  • Change From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 26 [ Time Frame: Baseline, Week 26 ]
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. A decrease in PASI score indicates improvement.
  • Percent Change From Baseline in PASI Score at Week 26 [ Time Frame: Baseline, Week 26 ]
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. A decrease in PASI score indicates improvement.
  • Percentage of Participants Achieving PASI 75/50/90/100 Responses at Week 26 [ Time Frame: Week 26 ]
    PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. PASI-75, 50, 90, and 100 responses are the percentage of participants with a Baseline PASI score ≥ 5 who achieved at least a 75%, 50%, 90%, or 100% reduction (improvement), respectively, from Baseline in PASI score at Week 26. A 100% reduction was considered complete clearance of psoriasis. Data presents the percentage of participants achieving PASI 75/50/90/100 responses at Week 26 among participants with a Baseline PASI score ≥ 5.
  • Percentage of Participants Achieving Physician's Global Assessment of Skin Psoriasis (PGA-S) "Clear" or "Minimal" at Week 26 [ Time Frame: Week 26 ]
    The PGA-S is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was assessed, with 0 indicating cleared and 5 indicating severe. A decrease in PGA-S score indicates improvement. Data present the percentage of participants achieving a PGA-S of "clear" (0) or "minimal" (1) with at least a 2-grade improvement relative to Baseline at Week 26.
  • Percentage of Participants Achieving PGA-S of "Clear" at Week 26 [ Time Frame: Week 26 ]
    The PGA-S is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was assessed, with 0 indicating cleared and 5 indicating severe. A decrease in PGA-S score indicates improvement. Data present the percentage of participants achieving a PGA-S of "clear" (0) with at least a 2-grade improvement relative to Baseline at Week 26.
  • Percentage of Participants Achieving 50% Improvement in the Inverse Psoriasis Component of the B-SNIPI at Week 26 [ Time Frame: Week 26 ]
    The range of possible B-SNIPI scores was 0 to 20 for inverse psoriasis, with a score of 0 indicating absence of psoriasis and a score of 20 indicating most severe psoriasis. A decrease in B-SNIPI score indicates improvement. Data presents the percentage of participants achieving 50% improvement in the inverse component of the B-SNIPI among participants with a Baseline inverse psoriasis score of ≥ 6.
  • Change From Baseline in Total Body Surface Area (BSA) at Week 26 [ Time Frame: Baseline, Week 26 ]
    BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.
  • Percent Change From Baseline in Total BSA at Week 26 [ Time Frame: Baseline, Week 26 ]
    BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.
  • Percent Change From Baseline in Nail Psoriasis Pain NRS at Week 26 [ Time Frame: Baseline, Week 26 ]
    An NRS was used to capture a participant's self-reporting of her/his worst fingernail pain and average fingernail pain due to fingernail psoriasis. The participant rated the severity of fingernail pain over the past 7 days on a scale from 0 indicating no pain, to 10 indicating severe pain. A negative change from Baseline indicates improvement.
  • Percent Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26 [ Time Frame: Baseline, Week 26 ]
    Participants were asked to rate the impact of their fingernail psoriasis on their ability to perform physical tasks (eg, typing, housework, buttoning a shirt or blouse, picking up coins from a table, tying shoes, yard work, etc.) over the past 7 days on a scale of 0 indicating no impact on ability to perform physical tasks, to 10 indicating severe impact on ability to perform physical tasks. A negative change from Baseline indicates improvement.
  • Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life (NAPPA QoL) at Week 26 [ Time Frame: Baseline, Week 26 ]
    Participants rated specific impacts of fingernail psoriasis on various aspects of their QoL over the past 7 days on a 5-point scale, with 0 indicating not at all, and 4 indicating very impactful. A participant's overall global score was the mean of all items and could range from 0 to 4, with 0 indicating no impact and 4 indicating most impact. A decrease in NAPPA QoL score indicates improvement.
  • Percent Change From Baseline in Nail Assessment in NAPPA QoL at Week 26 [ Time Frame: Baseline, Week 26 ]
    Participants rated specific impacts of fingernail psoriasis on various aspects of their QoL over the past 7 days on a 5-point scale, with 0 indicating not at all, and 4 indicating very impactful. A participant's overall global score was the mean of all items and could range from 0 to 4, with 0 indicating no impact and 4 indicating most impact. A decrease in NAPPA QoL score indicates improvement.
  • Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 26 [ Time Frame: Baseline, Week 26 ]
    Participants assessed symptoms and impacts of dermatologic diseases on their QoL over the past 7 days, with 0 indicating not at all, and 3 indicating very much. The range of possible DLQI scores was 0 to 30, with a score of 0 indicating no effect at all on a participant's life and a score of 30 indicating extremely large effect on participant's life. A decrease in DLQI score indicates improvement.
  • Percentage of Participants Achieving DLQI of 0 and 0/1 at Week 26 [ Time Frame: Week 26 ]
    Participants assessed symptoms and impacts of dermatologic diseases on their QoL over the past 7 days, with 0 indicating not at all, and 3 indicating very much. The range of possible DLQI scores was 0 to 30, with a score of 0 indicating no effect at all on a participant's life and a score of 30 indicating extremely large effect on participant's life. A decrease in DLQI score indicates improvement. Data presents the percentage of participants with a score of 0 (no effect) or 1 (little effect) at Week 26.
  • Change From Baseline in Work Productivity and Activity Impairment Nail Psoriasis (WPAI:NPSO) at Week 26 [ Time Frame: Baseline, Week 26 ]
    The WPAI: NPSO assessed impact of fingernail psoriasis on work productivity and non-work activity limitation. Participants were asked during the past 7 days, how many hours did you miss from work because of problems associated with your fingernail psoriasis (absenteeism), during the past seven days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your fingernail psoriasis affect your productivity while you were working (overall work impairment), and much did your fingernail psoriasis affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating "fingernail psoriasis had no effect on this" and 10 indicating "fingernail psoriasis completely prevented me from this." A decrease in the WPAI:NPSO score indicates improvement.
  • Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Health State Assessment at Week 26 [ Time Frame: Baseline, Week 26 ]
    The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement.
  • Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Week 26 [ Time Frame: Baseline, Week 26 ]
    The EQ-5D VAS records the participant's self-rated health status on a vertical graduated scale from 0 to 100, with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state. An increase in EQ-5D-5L VAS score indicates improvement.
  • Change From Baseline in Hospital Anxiety Depression Scale (HADS) at Week 26 [ Time Frame: Baseline, Week 26 ]
    Participants rated their anxiety and depression over the past 7 days at Week 26. The range of possible scores was 0 to 21, with a score of 0 indicating absence of anxiety and depression and 21 indicating the most severe anxiety and depression. A decrease in HADS score indicates improvement.
  • Percentage of Participants With a New Diagnosis of Psoriatic Arthritis (PsA) During the Study [ Time Frame: up to Week 26 ]
    The percentage of participants with a new diagnosis of PsA (ie, with an adverse event of PsA) during the study, among participants without PsA at Baseline.
  • Change From Baseline in Nail Psoriasis Quality of Life (Nail PsQoL) Score at Week 26 [ Time Frame: Baseline, Week 26 ]
    Participants were asked how their fingernail psoriasis impacted their overall quality of life over the past 7 days on an 11-point scale, with 0 indicating no impact, and 10 indicating severe impact. A negative change from Baseline indicates improvement.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
  • Percent change in total mNAPSI of all fingernails [ Time Frame: From Week 0 to Week 26 ]
  • Proportion of subjects achieving mNAPSI = 0 in all fingernails [ Time Frame: At Week 26 ]
    Subjects who achieve a mNAPSI score of 0
  • Change in Nail Psoriasis Pain Numeric Rating Scale (NRS) [ Time Frame: From Week 0 to Week 26 ]
  • Change in Nail Psoriasis Physical Functioning Severity Score [ Time Frame: From Week 0 to Week 26 ]
  • Change in Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life (NAPPA QoL) [ Time Frame: From Week 0 to Week 26 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: December 16, 2013)
  • Proportion of subjects achieving a total-fingernail mNAPSI 75 response [ Time Frame: At Week 26 ]
    Proportion of subjects with a 75% improvement in mNAPSI score
  • Proportion of subjects achieving PGA-F of "clear" or "minimal" [ Time Frame: At Week 26 ]
    Physician's assessment of patient's fingernails that meet definition of clear or minimal.
  • Proportion of subjects achieving "clear" or "minimal" in nail bed component of the PGA-F, among those with a nail bed component of "moderate" or worse. [ Time Frame: At Week 26 ]
    Physician's assessment of patient's fingernails that meet definition of clear or minimal among those with a nail bed component of "moderate" for worse.
  • Proportion of subjects achieving "clear" or "minimal" in nail matrix component of the PGA-F, among those with a nail matrix component of "moderate" or worse. [ Time Frame: At Week 26 ]
    Physician's assessment of patient's fingernails that meet definition of clear or minimal among those with a nail matrix component of "moderate" or worse.
  • Proportion of subjects achieving mNAPSI = 0 in target fingernail. [ Time Frame: At Week 26 ]
  • Proportion of subjects achieving mNAPSI = 0 of all fingernails [ Time Frame: At Week 26 ]
  • Proportion of subjects achieving mNAPSI ≤ 2 of the target fingernail [ Time Frame: At Week 26 ]
  • Proportion of subjects achieving mNAPSI ≤ 2 of all fingernails [ Time Frame: At Week 26 ]
  • Change in mNAPSI of the target fingernail [ Time Frame: From Week 0 to Week 26 ]
  • Change in mNAPSI score of all fingernails [ Time Frame: From Week 0 to Week 26 ]
  • Proportion of subjects achieving NAPSI=0 in all fingernails [ Time Frame: At Week 26 ]
  • Proportion of subjects achieving NAPSI=0 in target fingernail [ Time Frame: At Week 26 ]
  • Change in total NAPSI of target fingernail [ Time Frame: From Week 0 to Week 26 ]
  • Change in total NAPSI of all fingernails [ Time Frame: From Week 0 to Week 26 ]
  • Change in Psoriasis Area Severity Index (PASI) [ Time Frame: From Week 0 to Week 26 ]
  • Proportion of subjects achieving total PASI 75/50/90/100 among subjects with PASI score ≥ 5 [ Time Frame: At Week 26 ]
  • Proportion of subjects achieving physician's global assessment of skin psoriasis (PGA-S) "clear" or "minimal" [ Time Frame: At Week 26 ]
    Physician's assessment of patient's skin psoriasis that meets definition of clear or minimal
  • Change in total body surface area (BSA) [ Time Frame: From Week 0 to Week 26 ]
  • Change in Nail Psoriasis Pain Numeric Rating Scale (NRS) [ Time Frame: From Week 0 to Week 26 ]
  • Change in Nail Psoriasis Physical Functioning Severity Score [ Time Frame: From Week 0 to Week 26 ]
  • Change in Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life (NAPPA QoL) [ Time Frame: From Week 0 to Week 26 ]
  • Change in dermatology life quality index (DLQI) [ Time Frame: From Week 0 to Week 26 ]
  • Proportion of subjects achieving DLQI of 0, and achieving DLQI of 0/1 [ Time Frame: At Week 26 ]
  • Change in Work Productivity and Activity Impairment Nail Psoriasis (WPAI:NPSO) [ Time Frame: From Week 0 to Week 26 ]
  • Change in EuroQol-5Dimensions-5Levels (EQ-5D-5L) Health Status Assessment [ Time Frame: From Week 0 to Week 26 ]
  • Change in Hospital Anxiety Depression Scale (HADS) [ Time Frame: From Week 0 to Week 26 ]
  • Proportion of subjects with a new diagnosis of psoriatic arthritis (PsA) during the study (with adverse event of PsA) among subjects without PsA. [ Time Frame: At Week 26 ]
  • Change in Nail Psoriasis Quality of Life (Nail PsQoL) [ Time Frame: From Week 0 to Week 26 ]
  • Percent change in mNAPSI of the target fingernail [ Time Frame: From Week 0 to Week 26 ]
  • Percent change in mNAPSI score of all fingernails [ Time Frame: From Week 0 to Week 26 ]
  • Percent change in total NAPSI of target fingernail [ Time Frame: From Week 0 to Week 26 ]
  • Percent change in total NAPSI of all fingernails [ Time Frame: From Week 0 to Week 26 ]
  • Percent change in Psoriasis Area Severity Index (PASI) of all fingernails [ Time Frame: From Week 0 to Week 26 ]
  • Percent change in total body surface area (BSA) [ Time Frame: From Week 0 to Week 26 ]
  • Percent change in Nail Psoriasis Pain Numeric Rating Scale (NRS) [ Time Frame: From Week 0 to Week 26 ]
  • Percent change in Nail Psoriasis Physical Functioning Severity Score [ Time Frame: From Week 0 to Week 26 ]
  • Percent change in Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life (NAPPA QoL) [ Time Frame: From Week 0 to Week 26 ]
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Efficacy of Adalimumab in Subjects With Chronic Plaque Psoriasis and Nail Psoriasis
Official Title  ICMJE A Phase 3, Multicenter, Double-Blind, Randomized, Parallel-Arm, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Adalimumab for Treatment of Nail Psoriasis in Patients With Chronic Plaque Psoriasis
Brief Summary This study is being conducted to assess the safety and efficacy of adalimumab in participants with nail psoriasis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Nail Psoriasis
  • Plaque Psoriasis
Intervention  ICMJE
  • Biological: Adalimumab
    Other Names:
    • ABT-D2E7
    • Humira
  • Other: Placebo
Study Arms  ICMJE
  • Active Comparator: Adalimumab (ADA)
    Period A: ADA 40 mg subcutaneous every other week (sc eow) for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
    Interventions:
    • Biological: Adalimumab
    • Other: Placebo
  • Placebo Comparator: Placebo
    Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
    Interventions:
    • Biological: Adalimumab
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2016)
217
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2013)
200
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject must have body surface area (BSA) ≥ 10% and a target fingernail Modified Nail Psoriasis Severity Index (mNAPSI) ≥ 8 at Week 0, OR BSA ≥ 5%, a target fingernail mNAPSI ≥ 8 and a total mNAPSI score of ≥ 20 at Week 0.
  • Subject must have a Nail Psoriasis Physical Functioning Severity score of > 3, OR a Nail Psoriasis Pain Numeric Rating Scale (NRS) score of >3.
  • Subjects must have a Physician's Global Assessment (PGA) of Fingernail Psoriasis and a PGA of Skin Psoriasis of at least moderate.
  • Subject must have discontinued use of all systemic therapies for the treatment of psoriasis, or systemic therapies known to improve psoriasis for at least 4 weeks prior to Week 0, ustekinumab must have been discontinued at least 12 weeks prior to Week 0.
  • Target fingernail must have mNAPSI score of ≥ 8.
  • Adult subjects with clinical diagnosis of chronic plaque psoriasis (with disease duration of at least 6 months).

Exclusion Criteria:

  • Prior adalimumab therapy.
  • Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of skin or fingernail psoriasis.
  • Recent infection requiring treatment.
  • Significant medical events or conditions that may put patients at risk for participation, including recent history of drug or alcohol abuse.
  • Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.
  • History of cancer, except successfully treated skin cancer.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Australia,   Belgium,   Canada,   France,   Germany,   Greece,   Mexico,   Puerto Rico,   United States
 
Administrative Information
NCT Number  ICMJE NCT02016482
Other Study ID Numbers  ICMJE M13-674
2013-003275-36 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Williams, MD AbbVie
PRS Account AbbVie
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP