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Efficacy of Ustekinumab Followed by Abatacept for the Treatment of Psoriasis Vulgaris (PAUSE)

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Ustekinumab

Abatacept

UST Placebo

ABA Placebo

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring psoriasis vulgaris, ustekinumab, abatacept

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A diagnosis of plaque psoriasis for at least 6 months
Baseline Psoriasis Area and Severity Index (PASI) score >= 12
>=10% body surface area psoriasis involvement
Willingness to forgo other available psoriasis therapies, live vaccines, and pregnancy during the trial
Ability and willingness to provide informed consent and comply with study requirements

Exclusion Criteria:

Non-plaque forms of psoriasis
Grade 2 or 3 moderate to severe psoriatic arthritis not adequately managed with non-steroidal anti-inflammatory drugs (NSAIDs)
Myocardial infarction, unstable angina, cerebrovascular accident, or other significant cardiovascular event within the previous one year
Chronic obstructive pulmonary disease (COPD)
Comorbid condition that requires regular systemic corticosteroid treatment
History of malignancy, except treated basal cell skin carcinoma
Treated basal cell skin carcinoma within the previous 5 years
Severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, or neurological disease, or any other medical condition that, in the investigator's opinion, places the participant at risk by participating in this study
History of recent or ongoing uncontrolled bacterial, viral, fungal, or other opportunistic infections
Evidence of infection with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV)
Positive QuantiFERON-TB Gold test. Purified Protein Derivative (PPD) tuberculin test may be substituted for QuantiFERON-TB Gold test.
Severe reaction or anaphylaxis to any human monoclonal antibody
Any previous treatment with agents targeting Interleukin (IL)-12 or IL-23, including ustekinumab
Any previous treatment with abatacept
Treatment with biologic agents within previous 3 months, including adalimumab, etanercept, and infliximab
Treatment with immunosuppressive medications, including methotrexate, cyclosporine, oral retinoids, prednisone, or phototherapy within previous 4 weeks
Topical psoriasis treatment within previous 2 weeks, including topical corticosteroids, vitamin D analogues, retinoids, calcineurin inhibitors, salicylic acid, and coal tar
Investigational study medication within previous 6 months
Liver function test (aspartate aminotransferase [AST], alanine aminotransferase [ALT], or alkaline phosphatase) results that are >/= 2x the upper limit of normal (ULN).
Serum creatinine >= 2x the ULN.
Any of the following hematologic abnormalities, confirmed by repeat test at least 1 week apart:
1. White blood count <3,000/μL or >14,000/μL;
2. Lymphocyte count <1,000/μL;
3. Neutrophil count <1,500/μL;
4. Platelet count <150,000 /μL; or
5. Hemoglobin <10 g/dL.
Females who are pregnant, lactating, planning on pregnancy during the study period, or unwilling to use FDA-approved method of birth control
Receipt of a live vaccine (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox) in the 6 weeks before enrollment
BCG (Bacillus Calmette-Guérin) vaccine one year prior to enrollment

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

UST, ABA/UST Placebo

UST, UST/ABA Placebo

Arm Description

Participants received 2 subcutaneous injections of open-label ustekinumab (UST) (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and were then randomized to receive blinded (masked) treatment of abatacept (ABA) (125 mg) subcutaneous injections weekly from Week 12 to 39, in addition to ustekinumab placebo subcutaneous injections at Weeks 16 and 28.

Participants received 2 subcutaneous injections of open-label ustekinumab (UST) (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and were then randomized to receive blinded (masked) treatment of ustekinumab (45 mg if <=100 kg or 90 mg if >100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept (ABA) placebo subcutaneous injections weekly from Week 12 to 39.

Outcomes

Primary Outcome Measures

Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as Relapse)

The percentage of participants who experienced psoriasis relapse in the interval from Week 12 to 88. Psoriasis relapse is defined as loss of ≥ 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at Week 12. This occurs if the participant obtains a PASI score at any evaluation during the specified time interval that is ≥ Week 12 PASI + [(Baseline PASI -Week 12 PASI)/2]). Participants who terminated early from the study (drop-outs) were considered to have experienced relapse at time of drop-out. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).

Secondary Outcome Measures

Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as No Relapse)

The percentage of participants who experienced psoriasis relapse in the interval from Week 12 to 88. Psoriasis relapse is defined as loss of ≥ 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at Week 12 (Baseline PASI -Week 12 PASI). Participants who terminated early from the study due to reasons other than psoriasis relapse or worsening psoriasis (drop-outs) were considered to have not experienced relapse at time of drop-out. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).

Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as Missing Relapse Status)

The percentage of participants who experienced psoriasis relapse in the interval from Week 12 to 88. Psoriasis relapse is defined as loss of ≥ 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at Week 12 (Baseline PASI -Week 12 PASI). Participants who terminated early due to reasons other than psoriasis relapse or worsening psoriasis were considered to have a missing relapse status at time of drop-out and were excluded from the analyses. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).

Time to Psoriasis Relapse (Treating Drop-Outs as Relapse)

Time in weeks from Week 12 to psoriasis relapse. Psoriasis relapse is defined as loss of ≥ 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at Week 12. This occurs if the participant obtains a PASI score at any evaluation during the specified time interval that is ≥ Week 12 PASI + [(Baseline PASI -Week 12 PASI)/2]). Participants who terminated early from the study (drop-outs) were considered to have experienced relapse at time of drop-out. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).

Time to Psoriasis Relapse (Treating Drop-Outs as Censored)

Time in weeks from Week 12 to psoriasis relapse. Psoriasis relapse is defined as loss of ≥ 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at Week 12. This occurs if the participant obtains a PASI score at any evaluation during the specified time interval that is ≥ Week 12 PASI + [(Baseline PASI -Week 12 PASI)/2]). Participants who terminated early from the study due to reasons other than psoriasis relapse or worsening psoriasis (drop-outs) were censored at the time of drop-out. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).

Percentage of Participants Who Were Cleared or Minimal in the Physician's Global Assessment (PGA)

Percentage of participants who were classified as cleared or minimal in the Physician's Global Assessment (PGA) average score at the specified post-randomization time point. The PGA assesses the severity of the psoriasis in 3 components: induration, erythema and scaling. Each component is given a score ranging from 0 to 5 based on the majority of the participant's psoriasis lesions, with higher scores indicating worse disease. A PGA average score < 1.5 was classified as "cleared or minimal."

Change in Dermatology Life Quality Index (DLQI)

Change in the Dermatology Life Quality Index (DLQI) score from Week 12 to the specified post-randomization time point. DLQI is a 10-question, participant-reported questionnaire that assesses quality of life with respect to skin conditions in the areas of symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Each question measures the level of effect that the skin condition has on quality of life, and responses range from 'Not at all' (score = 0) to 'Very much' (score = 3). The overall score is the sum of the scores for all 10 questions and ranges from 0-30, with higher scores indicating worse quality of life.

Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Lead-in Phase)

Number of participants who experienced adverse events (AEs) during the lead-in phase (Week 0 to 12), classified by severity and type. AEs were classified by grade according to the National Cancer Institute's (NCI's) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03, and all Grade 2 or greater AEs were collected in the database. In addition, new onset or worsening psoriatic arthritis was separately collected and graded from 1 to 3 along a study-specific functional scale. AEs were also classified based on relatedness to study drug, whether they led to study drug discontinuation, and whether they were AEs of special interest as specified in the protocol.

Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Lead-in Phase)

Number of adverse events (AEs) that occurred during the lead-in phase (Week 0 to 12), classified by severity and type. AEs were classified by grade according to the National Cancer Institute's (NCI's) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03, and all Grade 2 or greater AEs were collected in the database. In addition, new onset or worsening psoriatic arthritis was separately collected and graded from 1 to 3 along a study-specific functional scale. AEs were also classified based on relatedness to study drug, whether they led to study drug discontinuation, and whether they were AEs of special interest as specified in the protocol.

Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Post-Randomization)

Number of participants who experienced adverse events (AEs) during the post-randomization phase (Week 12 to 100), classified by severity and type. AEs were classified by grade according to the National Cancer Institute's (NCI's) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03, and all Grade 2 or greater AEs were collected in the database. In addition, new onset or worsening psoriatic arthritis was separately collected and graded from 1 to 3 along a study-specific functional scale. AEs were also classified based on relatedness to study drug, whether they led to study drug discontinuation, and whether they were AEs of special interest as specified in the protocol. AEs that started prior to randomization but became serious after randomization were included in the counts for the post-randomization time period.

Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Post-Randomization)

Number of adverse events (AEs) that occurred during the post-randomization phase (Week 12 to 100), classified by severity and type. AEs were classified by grade according to the National Cancer Institute's (NCI's) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03, and all Grade 2 or greater AEs were collected in the database. In addition, new onset or worsening psoriatic arthritis was separately collected and graded from 1 to 3 along a study-specific functional scale. AEs were also classified based on relatedness to study drug, whether they led to study drug discontinuation, and whether they were AEs of special interest as specified in the protocol. AEs that started prior to randomization but became serious after randomization were included in the counts for the post-randomization time period.

Full Information

NCT ID

NCT01999868

First Posted

November 26, 2013

Last Updated

December 26, 2018

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Immune Tolerance Network (ITN)

1. Study Identification

Unique Protocol Identification Number

NCT01999868

Brief Title

Efficacy of Ustekinumab Followed by Abatacept for the Treatment of Psoriasis Vulgaris

Acronym

PAUSE

Official Title

Efficacy of Ustekinumab (Anti-IL-12/23) Followed by Abatacept (CTLA4-Ig) for the Treatment of Psoriasis Vulgaris (ITN059AI)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

March 19, 2014 (Actual)

Primary Completion Date

December 7, 2017 (Actual)

Study Completion Date

March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Immune Tolerance Network (ITN)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine if the use of ustekinumab, followed by abatacept, will prevent relapse in people with moderate to severe plaque psoriasis.

Detailed Description

Psoriasis is a chronic immune disease of the skin and joints that affects about 2% of the population. The most common form of psoriasis is plaque psoriasis, also called psoriasis vulgaris. A variety of drugs, including biologics, are available for treatment of moderate to severe psoriasis. When biologic agents are stopped, psoriasis can return (relapse) and often requires the biologic to be restarted and continued. No treatment program has been identified to prevent relapse of psoriasis. The study design has a lead-in period of weight-based ustekinumab treatment, with all participants receiving either 45 mg ustekinumab (<= 100 kg) or 90 mg ustekinumab (> 100 kg) administered subcutaneously at weeks 0 and 4. At week 12, participants will be assessed for a Psoriasis Area and Severity Index (PASI) 75 response to ustekinumab. Participants who do not achieve a PASI 75 score will be discontinued from the investigation and permitted to seek standard therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

psoriasis vulgaris, ustekinumab, abatacept

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

UST, ABA/UST Placebo

Arm Type

Experimental

Arm Description

Arm Title

UST, UST/ABA Placebo

Arm Type

Active Comparator

Arm Description

Participants received 2 subcutaneous injections of open-label ustekinumab (UST) (45 mg for participants weighing <=100 kg at study entry or 90 mg for those weighing >100 kg at study entry), at Weeks 0 and 4 during the lead-in phase and were then randomized to receive blinded (masked) treatment of ustekinumab (45 mg if <=100 kg or 90 mg if >100 kg at study entry) subcutaneous injections at Weeks 16 and 28, in addition to abatacept (ABA) placebo subcutaneous injections weekly from Week 12 to 39.

Intervention Type

Biological

Intervention Name(s)

Ustekinumab

Other Intervention Name(s)

anti-IL-12/23, Stelara

Intervention Description

Ustekinumab interferes with the actions of proteins, interleukin 12 (IL12) and interleukin 23 (IL23), which reduces inflammation (swelling) in the skin. Stelara™ is the trade name for ustekinumab and is approved by the U.S. Food and Drug Administration (FDA) to treat psoriasis. Dose: Participants who weigh <= 100 kg at study entry will receive 45 mg of ustekinumab. Participants who weigh > 100 kg at study entry will receive 90 mg of ustekinumab.

Intervention Type

Biological

Intervention Name(s)

Abatacept

Other Intervention Name(s)

CTLA4-Ig, cytotoxic T lymphocyte antigen immunoglobulin fusion protein, Orencia

Intervention Description

Abatacept (one form of the protein called CTLA4-Ig) interacts with the immune system, reducing the activity of T-cells and may prevent relapse. Orencia™ is the trade name for abatacept, and it is approved by the FDA to treat rheumatoid arthritis in adults. Dose: 125 mg sub-cutaneous injection

Intervention Type

Drug

Intervention Name(s)

UST Placebo

Other Intervention Name(s)

Placebo for Ustekinumab, Ustekinumab Placebo

Intervention Description

The abatacept treatment group will also receive subcutaneous placebo for ustekinumab (sterile normal saline) at week 16 and week 28, corresponding to the ustekinumab dosing regimen.

Intervention Type

Drug

Intervention Name(s)

ABA Placebo

Other Intervention Name(s)

Placebo for Abatacept, Abatacept Placebo

Intervention Description

The ustekinumab treatment group will also receive weekly subcutaneous injections of placebo for abatacept from week 12 to week 39, corresponding to the abatacept dosing regimen.

Primary Outcome Measure Information:

Title

Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as Relapse)

Description

Time Frame

Post-randomization (Week 12 to 88)

Secondary Outcome Measure Information:

Title

Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as No Relapse)

Description

The percentage of participants who experienced psoriasis relapse in the interval from Week 12 to 88. Psoriasis relapse is defined as loss of ≥ 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at Week 12 (Baseline PASI -Week 12 PASI). Participants who terminated early from the study due to reasons other than psoriasis relapse or worsening psoriasis (drop-outs) were considered to have not experienced relapse at time of drop-out. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).

Time Frame

Post-randomization (Week 12 to 88)

Title

Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as Missing Relapse Status)

Description

The percentage of participants who experienced psoriasis relapse in the interval from Week 12 to 88. Psoriasis relapse is defined as loss of ≥ 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at Week 12 (Baseline PASI -Week 12 PASI). Participants who terminated early due to reasons other than psoriasis relapse or worsening psoriasis were considered to have a missing relapse status at time of drop-out and were excluded from the analyses. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).

Time Frame

Post-randomization (Week 12 to 88)

Title

Time to Psoriasis Relapse (Treating Drop-Outs as Relapse)

Description

Time Frame

Post-randomization (Week 12 to 88)

Title

Time to Psoriasis Relapse (Treating Drop-Outs as Censored)

Description

Time in weeks from Week 12 to psoriasis relapse. Psoriasis relapse is defined as loss of ≥ 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at Week 12. This occurs if the participant obtains a PASI score at any evaluation during the specified time interval that is ≥ Week 12 PASI + [(Baseline PASI -Week 12 PASI)/2]). Participants who terminated early from the study due to reasons other than psoriasis relapse or worsening psoriasis (drop-outs) were censored at the time of drop-out. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).

Time Frame

Post-randomization (Week 12 to 88)

Title

Percentage of Participants Who Were Cleared or Minimal in the Physician's Global Assessment (PGA)

Description

Time Frame

Week 40, Week 88

Title

Change in Dermatology Life Quality Index (DLQI)

Description

Time Frame

Week 40, Week 88

Title

Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Lead-in Phase)

Description

Time Frame

Lead-In Phase (Week 0 to 12)

Title

Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Lead-in Phase)

Description

Time Frame

Lead-In Phase (Week 0 to 12)

Title

Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Post-Randomization)

Description

Time Frame

From randomization (Week 12) to last safety follow-up visit (up to Week 100)

Title

Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Post-Randomization)

Description

Time Frame

From randomization (Week 12) to last safety follow-up visit (up to Week 100)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A diagnosis of plaque psoriasis for at least 6 months Baseline Psoriasis Area and Severity Index (PASI) score >= 12 >=10% body surface area psoriasis involvement Willingness to forgo other available psoriasis therapies, live vaccines, and pregnancy during the trial Ability and willingness to provide informed consent and comply with study requirements Exclusion Criteria: Non-plaque forms of psoriasis Grade 2 or 3 moderate to severe psoriatic arthritis not adequately managed with non-steroidal anti-inflammatory drugs (NSAIDs) Myocardial infarction, unstable angina, cerebrovascular accident, or other significant cardiovascular event within the previous one year Chronic obstructive pulmonary disease (COPD) Comorbid condition that requires regular systemic corticosteroid treatment History of malignancy, except treated basal cell skin carcinoma Treated basal cell skin carcinoma within the previous 5 years Severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, or neurological disease, or any other medical condition that, in the investigator's opinion, places the participant at risk by participating in this study History of recent or ongoing uncontrolled bacterial, viral, fungal, or other opportunistic infections Evidence of infection with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV) Positive QuantiFERON-TB Gold test. Purified Protein Derivative (PPD) tuberculin test may be substituted for QuantiFERON-TB Gold test. Severe reaction or anaphylaxis to any human monoclonal antibody Any previous treatment with agents targeting Interleukin (IL)-12 or IL-23, including ustekinumab Any previous treatment with abatacept Treatment with biologic agents within previous 3 months, including adalimumab, etanercept, and infliximab Treatment with immunosuppressive medications, including methotrexate, cyclosporine, oral retinoids, prednisone, or phototherapy within previous 4 weeks Topical psoriasis treatment within previous 2 weeks, including topical corticosteroids, vitamin D analogues, retinoids, calcineurin inhibitors, salicylic acid, and coal tar Investigational study medication within previous 6 months Liver function test (aspartate aminotransferase [AST], alanine aminotransferase [ALT], or alkaline phosphatase) results that are >/= 2x the upper limit of normal (ULN). Serum creatinine >= 2x the ULN. Any of the following hematologic abnormalities, confirmed by repeat test at least 1 week apart: White blood count <3,000/μL or >14,000/μL; Lymphocyte count <1,000/μL; Neutrophil count <1,500/μL; Platelet count <150,000 /μL; or Hemoglobin <10 g/dL. Females who are pregnant, lactating, planning on pregnancy during the study period, or unwilling to use FDA-approved method of birth control Receipt of a live vaccine (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox) in the 6 weeks before enrollment BCG (Bacillus Calmette-Guérin) vaccine one year prior to enrollment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Krueger, MD, PhD

Organizational Affiliation

The Rockefeller University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dermatology Research Associates

City

Los Angeles

State/Province

California

ZIP/Postal Code

90045

Country

United States

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Tulane University School of Medicine: Dept. of Dermatology

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

The Rockefeller University

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Wake Forest University

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27104

Country

United States

Facility Name

Case Western University

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

The University of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

Kirk Barber Research

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2G 1B1

Country

Canada

Facility Name

Innovaderm Research Inc.

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2K 4L5

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

34643650

Citation

Harris KM, Smilek DE, Byron M, Lim N, Barry WT, McNamara J, Garcet S, Konrad RJ, Stengelin M, Bathala P, Korman NJ, Feldman SR, Boh EE, Barber K, Laumann AE, Helfrich YR, Krueger GG, Sofen H, Bissonnette R, Krueger JG. Effect of Costimulatory Blockade With Abatacept After Ustekinumab Withdrawal in Patients With Moderate to Severe Plaque Psoriasis: The PAUSE Randomized Clinical Trial. JAMA Dermatol. 2021 Nov 1;157(11):1306-1315. doi: 10.1001/jamadermatol.2021.3492.

Results Reference

derived

Links:

URL

https://www.niaid.nih.gov/

Description

National Institute of Allergy and Infectious Diseases (NIAID) website

URL

http://www.immunetolerance.org

Description

Immune Tolerance Network (ITN) website

URL

http://www.pausestudy.org/

Description

PAUSE (ITN059AI) ITN Study website

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Efficacy of Ustekinumab Followed by Abatacept for the Treatment of Psoriasis Vulgaris

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Efficacy of Ustekinumab Followed by Abatacept for the Treatment of Psoriasis Vulgaris (PAUSE)

Psoriasis

About this trial

Eligibility Criteria

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Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial