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Completed

NCT Number: NCT01251614

A Double Blind Study in Pediatric Subjects With Chronic Plaque Psoriasis, Studying Adalimumab vs. Methotrexate

This study will compare how well adalimumab works versus methotrexate (MTX) in children with moderate to severe psoriasis in the short term. It will also study how safe and how well adalimumab works in the long term and how long disease response can be maintained after stopping therapy.

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Key information

Conditions

Plaque Psoriasis

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

The study had a 30-day screening period and a multi-period study design, as described below:

Period A - Primary Treatment Phase: Participants were randomized to receive adalimumab 0.8 mg/kg, adalimumab 0.4 mg/kg, or MTX in 1:1:1 ratio for 16 weeks.

Period B - Treatment Withdrawal Phase: Responders were withdrawn from active treatment and monitored for loss of disease control for up to 36 weeks.

Period C - Re-Treatment Phase: Participants who had experienced loss of disease control in Period B were re-treated with adalimumab for 16 weeks.

Period D - Long-Term Follow-Up Phase: Participants received adalimumab or were observed off-treatment (if disease remained under control) for 52 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is ≥ 4 years and < 18 years of age;
  • Subject weighs ≥ 13 kg;
  • Subject must have failed to respond to topical therapy;
  • Subject must need systemic treatment to control his/her disease and meet one of the following:
  • Physician's Global Assessment (PGA) ≥ 4
  • Body surface area (BSA) involved > 20%
  • Very thick lesions with BSA > 10%
  • Psoriasis Area and Severity Index (PASI) > 20
  • PASI > 10 and at least one of the following:
  • Active psoriatic arthritis unresponsive to non-steroid anti-inflammatory drugs (NSAIDs)
  • Clinically relevant facial involvement
  • Clinically relevant genital involvement
  • Clinically relevant hand and/or foot involvement
  • Children's Dermatology Life Quality Index (CDLQI) > 10
  • If subject is < 12 years of age and resides in a geographic region where heliotherapy is practical, subject must have failed to respond, be intolerant, or have a contraindication to heliotherapy, or is not a suitable candidate for heliotherapy;
  • If ≥ 12 years of age, subject must have failed to respond, be intolerant, or have a contraindication to phototherapy, or is not a suitable candidate for phototherapy;
  • Subject must have a clinical diagnosis of psoriasis for at least 6 months as determined by the subject's medical history and confirmation of diagnosis through physical examination by the Investigator;
  • Subject must have stable plaque psoriasis for at least 2 months prior to Baseline

Exclusion criteria

  • Prior biologic use other than prior treatment with etanercept;
  • Treatment with etanercept therapy within 4 weeks prior to the Baseline visit; 3. Methotrexate (MTX) use within the past year or prior MTX use at any time where the subject did not respond, or did not tolerate MTX;
  • Contraindication for treatment with MTX during the study; 5. Erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication exacerbated psoriasis or new onset guttate psoriasis; 6. Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Baseline Visit or oral anti-infectives within 14 days prior to the Baseline Visit; 7. Treatment of psoriasis with topical therapies such as corticosteroids, vitamin D analogs, or retinoids within 7 days prior to the Baseline visit; 8. Treatment of psoriasis with ultraviolet (UV)B phototherapy, excessive sun exposure, or the use of tanning beds within 7 days prior to the Baseline visit; 9. Treatment of psoriasis with ultraviolet A with psoralen (PUVA) phototherapy, non-biologic systemic therapies for the treatment of psoriasis, or systemic therapies known to improve psoriasis within 14 days prior to the Baseline visit.

Treatment and study plan

Adalimumab

Biological

Adalimumab by subcutaneous injection every other week (eow)

Other names: ABT-D2E7, Humira

methotrexate

Drug

Methotrexate 0.1 mg/kg at Week 0 and up to 0.4 mg/kg per week (maximum dose of 25 mg/week) orally.

Placebo to Adalimumab

Biological

A single subcutaneous loading dose at Week 0 followed by eow dosing beginning at Week 1.

Placebo to methotrexate

Drug

Orally once a week

Primary outcomes

  1. Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 75 Response at Week 16

    Time frame: Baseline and Week 16

    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 (no psoriasis) to 72 (very severe psoriasis). A PASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in PASI score at Week 16.

  2. Percentage of Participants Achieving a Physician's Global Assessment of Disease Activity (PGA) of "Cleared" (0) or "Minimal" (1) at Week 16

    Time frame: Week 16

    The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories:

    • 0 (Cleared): No evidence of scaling, erythema, or plaque elevation;
    • 1 (Minimal): Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation;
    • 2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation;
    • 3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation;
    • 4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation;
    • 5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation.

    The percentage of participants achieving a score of clear (0) or minimal (1) is reported.

Secondary outcomes

  1. Percentage of Participants Who Achieved a PASI 90 Response at Week 16

    Time frame: Baseline and Week 16

    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 (no psoriasis) to 72 (very severe psoriasis).

    A PASI 90 response is at least a 90% reduction (improvement) from Baseline in PASI score at Week 16.

  2. Percentage of Participants Who Achieved a PASI 100 Response at Week 16

    Time frame: Baseline and Week 16

    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 (no psoriasis) to 72 (very severe psoriasis).

    A PASI 100 response is a 100% reduction (improvement) from Baseline in PASI score at Week 16.

  3. Change From Baseline in the Children's Dermatology Life Quality Index (CDLQI) Score at Week 16

    Time frame: Baseline and Week 16

    The Children's Dermatology Life Quality Index (CDLQI) is a 10-item questionnaire to measure the quality of life in children aged from 4 to 16 years. Each question is scored from 0 (not at all) to 3 (very much). The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

  4. Change From Baseline in the Pediatric Quality of Life Inventory (PedsQL) Score at Week 16

    Time frame: Baseline and Week 16

    The PedsQL Measurement Model measures health-related quality of life (HRQOL) in children and adolescents. The 23-item PedsQL Generic Core Scale includes Physical, Emotional, Social, School Functioning dimensions. Each item is scored from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL; the total score therefore ranges from 0 (worst) to 100 (best).

  5. Percentage of Participants Achieving a PGA of "Cleared" (0) or "Minimal" (1) Upon Re-Treatment in Period C

    Time frame: Period C, Week 16

    The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories: 0 (Cleared): No evidence of scaling, erythema, or plaque elevation; 1 (Minimal): Occasional fine scale over < 5% of lesions, faint erythema, minimal plaque elevation; 2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation; 3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation; 4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation; 5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation. The percentage of participants achieving a score of clear (0) or minimal (1) is reported.

  6. Time to Loss of Disease Control for Participants Who Entered Period B

    Time frame: Period B (36 weeks) and Period D (52 weeks)

    Loss of disease control was defined as a worsening of PGA scores in comparison to Week 16 of Period A by at least 2 grades after treatment withdrawal. The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. Scores range from 0 (no evidence of scaling, erythema, or plaque elevation) to 5 (very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation).

    Participants who did not lose disease control in period B continued off drug into period D and were observed off-drug until they finally lost disease control or until the end of the 52 weeks of period D.

  7. Percentage of Participants Achieving a PGA of "Cleared" (0) or "Minimal" (1) Over Time

    Time frame: Period A, Weeks 4, 8 and 11, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52

    The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories: 0 (Cleared): No evidence of scaling, erythema, or plaque elevation; 1 (Minimal): Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation; 2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation; 3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation; 4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation; 5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation. The percentage of participants achieving a score of clear (0) or minimal (1) is reported.

  8. Percentage of Participants Achieving a PGA of "Cleared" (0) Over Time

    Time frame: Period A, Weeks 4, 8, 11 and 16, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52

    The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories: 0 (Cleared): No evidence of scaling, erythema, or plaque elevation; 1 (Minimal): Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation; 2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation; 3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation; 4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation; 5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation.

    The percentage of participants achieving a score of clear (0) is reported.

  9. Percentage of Participants Who Achieved a PASI 50 Response Over Time

    Time frame: Baseline, Period A, Weeks 4, 8, 11 and 16, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52

    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 (no psoriasis) to 72 (very severe psoriasis).

    A PASI 50 response is at least a 50% reduction (improvement) from Baseline in PASI score.

  10. Percentage of Participants Who Achieved a PASI 75 Response Over Time

    Time frame: Baseline, Period A, Weeks 4, 8, and 11, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52

    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 (no psoriasis) to 72 (very severe psoriasis).

    A PASI 75 response is at least a 75% reduction (improvement) from Baseline in PASI score.

  11. Percentage of Participants Who Achieved a PASI 90 Response Over Time

    Time frame: Baseline, Period A, Weeks 4, 8 and 11, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52

    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 (no psoriasis) to 72 (very severe psoriasis).

    A PASI 90 response is at least a 90% reduction (improvement) from Baseline in PASI score.

  12. Percentage of Participants Who Achieved a PASI 100 Response Over Time

    Time frame: Baseline, Period A, Weeks 4, 8, and 11, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52

    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 (no psoriasis) to 72 (very severe psoriasis).

    A PASI 100 response is a 100% reduction (improvement) from Baseline in PASI score.

  13. Percent Change From Baseline in PASI Score Over Time

    Time frame: Baseline, Period A, Weeks 4, 8, 11 and 16, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52

    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 (no psoriasis) to 72 (very severe psoriasis).

  14. Change From Baseline in CDLQI Over Time

    Time frame: Baseline, Period A, Weeks 4, and 8, Period C, Weeks 0 and 4, Period D, Weeks 0, 11, 28, and 52

    The Children's Dermatology Life Quality Index (CDLQI) is a 10-item questionnaire to measure the quality of life in children aged from 4 to 16 years. Each question is scored from 0 (not at all) to 3 (very much). The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

  15. Percentage of Participants With CDLQI = 0 Over Time

    Time frame: Period A, Weeks 4, 8 and 16, Period C, Weeks 0 and 4, Period D, Weeks 0, 11, 28, and 52

    The Children's Dermatology Life Quality Index (CDLQI) is a 10-item questionnaire to measure the quality of life in children aged from 4 to 16 years. Each question is scored from 0 (not at all) to 3 (very much). The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired and a score of 0 indicates no impairment in quality of life.

  16. Time to PASI 50/75/90/100 Response in Period A

    Time frame: Period A, 16 weeks

    Participants who did not have a response during Period A were censored.

  17. Change From Baseline in PedsQL Over Time

    Time frame: Baseline, Period A, Weeks 4 and 8, Period C, Weeks 0 and 4, Period D, Weeks 0, 11, 28, and 52

    The PedsQL Measurement Model measures health-related quality of life (HRQOL) in children and adolescents. The 23-item PedsQL Generic Core Scale includes Physical, Emotional, Social, School Functioning dimensions. Each item is scored from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL; the total score therefore ranges from 0 (worst) to 100 (best).

  18. Change From Baseline in the Children's Depression Inventory: Short (CDI:S)

    Time frame: Baseline, Period A, Weeks 4, 8, and 16

    The CDI:S is a short 10-item self-rated symptom-oriented scale used to screen for depressive symptoms. CDI:S scores range from 0 to 100, with a lower score indicating fewer depressive symptoms.

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-dummy, Double-blind Study Evaluating Two Doses of Adalimumab Versus Methotrexate (MTX) in Pediatric Subjects With Chronic Plaque Psoriasis (Ps)

Important dates

Study start
2010
Primary completion
2013
Study completion
2015
First posted
Dec 2, 2010
Registry last updated
Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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