Back to resultsA Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (BE OPTIMAL)
Primary Purpose
Psoriatic Arthritis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bimekizumab
Adalimumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Psoriatic Arthritis, PsA, Bimekizumab
Eligibility Criteria
Inclusion Criteria:
- An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject
- Subject is male or female at least 18 years of age
- Female subject must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
- Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) >=3 out of 68 and swollen joint count (SJC) >=3 out of 66
- Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies
- Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO)
- Subject must be a suitable candidate for treatment with adalimumab and has no contraindications to receive adalimumab as per the local label as assessed by the Investigator
- Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry
Exclusion Criteria:
- Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
- Subjects with current or prior exposure to any biologics for the treatment of Psoriatic Arthritis (PsA) or Psoriasis (PSO)
- Subject has an active infection or a history of recent serious infections
- Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
- Subject has a diagnosis of inflammatory conditions other than PSO or PsA. Subjects with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease at Screening or Baseline
- Subject had acute anterior uveitis within 6 weeks of Baseline
- Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
- Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and guttate PSO, or drug-induced PSO)
- Presence of active suicidal ideation, or moderately severe major depression or severe major depression
- Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening
Sites / Locations
- Pa0010 50017
- Pa0010 50035
- Pa0010 50004
- Pa0010 50033
- Pa0010 50037
- Pa0010 50039
- Pa0010 50028
- Pa0010 50015
- Pa0010 50016
- Pa0010 50029
- Pa0010 50010
- Pa0010 50125
- Pa0010 50040
- Pa0010 50020
- Pa0010 50006
- Pa0010 50008
- Pa0010 50007
- Pa0010 50001
- Pa0010 50012
- Pa0010 50002
- Pa0010 50049
- Pa0010 50051
- Pa0010 50036
- Pa0010 50009
- Pa0010 50050
- Pa0010 30005
- Pa0010 30002
- Pa0010 30008
- Pa0010 30003
- Pa0010 30007
- Pa0010 30006
- Pa0010 40003
- Pa0010 40002
- Pa0010 40059
- Pa0010 50041
- Pa0010 50042
- Pa0010 50043
- Pa0010 50044
- Pa0010 40061
- Pa0010 40065
- Pa0010 40062
- Pa0010 40009
- Pa0010 40013
- Pa0010 40066
- Pa0010 40014
- Pa0010 40063
- Pa0010 40015
- Pa0010 40010
- Pa0010 40012
- Pa0010 40019
- Pa0010 40068
- Pa0010 40074
- Pa0010 40025
- Pa0010 40028
- Pa0010 40076
- Pa0010 40023
- Pa0010 40117
- Pa0010 40029
- Pa0010 40071
- Pa0010 40027
- Pa0010 40078
- Pa0010 40348
- Pa0010 40026
- Pa0010 40081
- Pa0010 40083
- Pa0010 40032
- Pa0010 40030
- Pa0010 40082
- Pa0010 40079
- Pa0010 40080
- Pa0010 40033
- Pa0010 40084
- Pa0010 40087
- Pa0010 40085
- Pa0010 40086
- Pa0010 20035
- Pa0010 20043
- Pa0010 20036
- Pa0010 20049
- Pa0010 20045
- Pa0010 20044
- Pa0010 20033
- Pa0010 20041
- Pa0010 20046
- Pa0010 20048
- Pa0010 20031
- Pa0010 20042
- Pa0010 20032
- Pa0010 20030
- Pa0010 40093
- Pa0010 40119
- Pa0010 40038
- Pa0010 40088
- Pa0010 40096
- Pa0010 40042
- Pa0010 40092
- Pa0010 40037
- Pa0010 40091
- Pa0010 40044
- Pa0010 40090
- Pa0010 40118
- Pa0010 40041
- Pa0010 40094
- Pa0010 40097
- Pa0010 40098
- Pa0010 40039
- Pa0010 40043
- Pa0010 40095
- Pa0010 20002
- Pa0010 20005
- Pa0010 20010
- Pa0010 20017
- Pa0010 20013
- Pa0010 20012
- Pa0010 20016
- Pa0010 20001
- Pa0010 20003
- Pa0010 20004
- Pa0010 20009
- Pa0010 20083
- Pa0010 20007
- Pa0010 20014
- Pa0010 20006
- Pa0010 20008
- Pa0010 20015
- Pa0010 40045
- Pa0010 40105
- Pa0010 40102
- Pa0010 40101
- Pa0010 40104
- Pa0010 40049
- Pa0010 40103
- Pa0010 40106
- Pa0010 40099
- Pa0010 40111
- Pa0010 40107
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Bimekzumab dosage regimen
Adalimumab dosage regimen
Placebo
Arm Description
Subjects randomized to this arm will receive assigned bimekizumab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.
Subjects randomized to this arm will receive the assigned adalimumab dosage regimen during the Treatment Period.
Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and will be reallocated to receive bimekizumab dosage regimen during the Maintenance Period.
Outcomes
Primary Outcome Measures
American College of Rheumatology (ACR) 50 response at Week 16
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline.
Secondary Outcome Measures
Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16
HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from baseline is computed as the value at Week 16 minus the baseline value. A negative value in change from baseline indicates an improvement.
Psoriasis Area Severity Index 90 (PASI90) response at Week 4 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline
The Psoriasis Area Severity Index 90 (PASI90) response is based on at least 90% improvement in the PASI score compared to Baseline.
The PASI is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.
Psoriasis Area Severity Index 90 (PASI90) response at Week 16 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline
The Psoriasis Area Severity Index 90 (PASI90) response is based on at least 90% improvement in the PASI score compared to Baseline.
The PASI is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.
Change from Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) at Week 16
There are 8 SF-36 domain scores. In addition to domain scores, the PCS scores are calculated from the 8 domains. Each of the 8 domain scores and the component summary scores ranging from 0 to 100, with higher scores indicating better health status. A larger positive value in change from Baseline indicates an improvement.
Minimal Disease Activity (MDA) at Week 16
Minimal Disease Activity (MDA) is a state of disease activity deemed a useful target of treatment by both the patient and physician, given current treatment possibilities and limitations. Criteria covering all domains of the disease have been developed to determine whether or not a patient has reached MDA based on key outcome measures in Psoriatic Arthritis (PsA).
A subject is considered as having MDA if 5 or more of the following 7 criteria are fulfilled: 1) Tender joint count <=1, 2) Swollen joint count <=1, 3) PASI <=1 or BSA <=3; 4) Patient pain Visual Analog Scale (VAS) <=15, 5) Patient global activity VAS <=20, 6) Health Assessment Questionnaire - Disability Index (HAQ-DI) <=0.5 and 7) Tender enthesial points <=1
Change from Baseline in Van der Heijde modified Total Sharp Score (vdHmTSS) in subjects with elevated hs-CRP and/or at least 1 bone erosion at Baseline at Week 16
The degree of joint damage is to be assessed using the vdHmTSS as used in the evaluation of Psoriatic Arthritis (PsA) compared to Baseline. This methodology quantifies the extent of joint erosions and joint space narrowing for 64 and 52 joints, respectively, with higher scores representing greater damage.
Enthesitis-free state in the Leeds Enthesitis Index (LEI) at Week 16 in the subgroup of subjects with enthesitis at Baseline in the pooled population of PA0010 and PA0011
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis by palpation on the lateral epicondyles of the humerus (elbows), medial femoral epicondyles (knees), and Achilles tendons (heels) bilaterally and scored as 0=no pain and 1=painful at Baseline.
Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 16 in the subgroup of subjects with dactylitis at Baseline in the pooled population of PA0010 and PA0011
Presence of dactylitis will be assessed in the subgroup of subjects with dactylitis using the LDI basic which evaluates for a >=10% difference in the circumference of the digit compared to the opposite digit this is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present) at Baseline.
American College of Rheumatology (ACR) 20 response at Week 16
The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline.
Change from Baseline in Van der Heijde modified Total Sharp Score (vdHmTSS) in the overall population at Week 16
The degree of joint damage is to be assessed using the vdHmTSS as used in the evaluation of Psoriatic Arthritis (PsA) compared to Baseline. This methodology quantifies the extent of joint erosions and joint space narrowing for 64 and 52 joints, respectively, with higher scores representing greater damage.
American College of Rheumatology (ACR) 70 response at Week 16
The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline.
Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 4 in the subset of subjects with psoriatic skin lesions at Baseline
Investigator Global Assessment (IGA) response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.
Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 16 in the subset of subjects with psoriatic skin lesions at Baseline
Investigator Global Assessment (IGA) response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.
Change from Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16: PtAAP Visual Analog Scale (VAS)
The PtAAP Visual Analog Scale (VAS) or 'Pain VAS' is part of the American College of Rheumatology (ACR) core set of measures in arthritis. Subjects will assess their arthritis pain using a VAS where 0 is "no pain" and 100 is "most severe pain."
Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 16 in the subgroup of subjects with enthesitis at Baseline
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis at Baseline. The SPARCC is an index that measures the severity of enthesitis through the assessment of 16 sites. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, for an overall score range of 0 to 16.
Change from Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) total score at Week 16
The PsAID-12 total score is a patient-reported outcome measure for assessing the impact of Psoriatic Arthritis (PsA) in 12 physical and psychological domains, including pain, fatigue, skin problems, work and/or leisure activities, functional capacity, discomfort, sleep disturbance, coping, anxiety/fear/uncertainty, embarrassment and/or shame, social participation, and depression. Each domain is assessed with a single question using a 0 to 10 numerical rating scale. Each domain score is multiplied by a weighting factor and the results are then summed to provide the total score. The total score ranges from 0 to 10, with higher scores indicating a worse status. A score below 4 out of 10 is considered a patient-acceptable status. A change of 3 or more points is considered relevant absolute change.
Incidence of treatment-emergent adverse events (TEAEs) during the study
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Incidence of treatment-emergent serious adverse events (SAEs) during the study
A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
Results in death
Is life-threatening
Requires in patient hospitalization or prolongation of existing hospitalization
Is a congenital anomaly or birth defect
Is an infection that requires treatment parenteral antibiotics
Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Incidence of treatment-emergent adverse events (TEAEs) leading to withdrawal from investigational medicinal product (IMP) during the study
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03895203
Brief Title
A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Acronym
BE OPTIMAL
Official Title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Reference (Adalimumab) Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 3, 2019 (Actual)
Primary Completion Date
August 17, 2021 (Actual)
Study Completion Date
July 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of subjects with active Psoriatic Arthritis (PsA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
Psoriatic Arthritis, PsA, Bimekizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
852 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bimekzumab dosage regimen
Arm Type
Experimental
Arm Description
Subjects randomized to this arm will receive assigned bimekizumab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.
Arm Title
Adalimumab dosage regimen
Arm Type
Active Comparator
Arm Description
Subjects randomized to this arm will receive the assigned adalimumab dosage regimen during the Treatment Period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and will be reallocated to receive bimekizumab dosage regimen during the Maintenance Period.
Intervention Type
Drug
Intervention Name(s)
Bimekizumab
Other Intervention Name(s)
BKZ, UCB4940
Intervention Description
Subjects will receive bimekizumab at pre-specified time-points.
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
HUMIRA®
Intervention Description
Adalimumab will be administered according to the labeling recommendations.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
PBO
Intervention Description
Subjects will receive placebo at pre-specified time-points.
Primary Outcome Measure Information:
Title
American College of Rheumatology (ACR) 50 response at Week 16
Description
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16
Description
HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from baseline is computed as the value at Week 16 minus the baseline value. A negative value in change from baseline indicates an improvement.
Time Frame
Baseline, Week 16
Title
Psoriasis Area Severity Index 90 (PASI90) response at Week 4 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline
Description
The Psoriasis Area Severity Index 90 (PASI90) response is based on at least 90% improvement in the PASI score compared to Baseline.
The PASI is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.
Time Frame
Baseline, Week 4
Title
Psoriasis Area Severity Index 90 (PASI90) response at Week 16 in the subgroup of subjects with psoriasis (PSO) involving at least 3% body surface area (BSA) at Baseline
Description
The Psoriasis Area Severity Index 90 (PASI90) response is based on at least 90% improvement in the PASI score compared to Baseline.
The PASI is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI=average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.
Time Frame
Baseline, Week 16
Title
Change from Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) at Week 16
Description
There are 8 SF-36 domain scores. In addition to domain scores, the PCS scores are calculated from the 8 domains. Each of the 8 domain scores and the component summary scores ranging from 0 to 100, with higher scores indicating better health status. A larger positive value in change from Baseline indicates an improvement.
Time Frame
Baseline, Week 16
Title
Minimal Disease Activity (MDA) at Week 16
Description
Minimal Disease Activity (MDA) is a state of disease activity deemed a useful target of treatment by both the patient and physician, given current treatment possibilities and limitations. Criteria covering all domains of the disease have been developed to determine whether or not a patient has reached MDA based on key outcome measures in Psoriatic Arthritis (PsA).
A subject is considered as having MDA if 5 or more of the following 7 criteria are fulfilled: 1) Tender joint count <=1, 2) Swollen joint count <=1, 3) PASI <=1 or BSA <=3; 4) Patient pain Visual Analog Scale (VAS) <=15, 5) Patient global activity VAS <=20, 6) Health Assessment Questionnaire - Disability Index (HAQ-DI) <=0.5 and 7) Tender enthesial points <=1
Time Frame
Week 16
Title
Change from Baseline in Van der Heijde modified Total Sharp Score (vdHmTSS) in subjects with elevated hs-CRP and/or at least 1 bone erosion at Baseline at Week 16
Description
The degree of joint damage is to be assessed using the vdHmTSS as used in the evaluation of Psoriatic Arthritis (PsA) compared to Baseline. This methodology quantifies the extent of joint erosions and joint space narrowing for 64 and 52 joints, respectively, with higher scores representing greater damage.
Time Frame
Baseline, Week 16
Title
Enthesitis-free state in the Leeds Enthesitis Index (LEI) at Week 16 in the subgroup of subjects with enthesitis at Baseline in the pooled population of PA0010 and PA0011
Description
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis by palpation on the lateral epicondyles of the humerus (elbows), medial femoral epicondyles (knees), and Achilles tendons (heels) bilaterally and scored as 0=no pain and 1=painful at Baseline.
Time Frame
Baseline, Week 16
Title
Dactylitis-free state based on the Leeds Dactylitis Index (LDI) at Week 16 in the subgroup of subjects with dactylitis at Baseline in the pooled population of PA0010 and PA0011
Description
Presence of dactylitis will be assessed in the subgroup of subjects with dactylitis using the LDI basic which evaluates for a >=10% difference in the circumference of the digit compared to the opposite digit this is then multiplied by the tenderness score, using a simple grading system (0=absent, 1=present) at Baseline.
Time Frame
Baseline, Week 16
Title
American College of Rheumatology (ACR) 20 response at Week 16
Description
The ACR20 response rate is based on a 20% or greater improvement of arthritis relative to Baseline.
Time Frame
Week 16
Title
Change from Baseline in Van der Heijde modified Total Sharp Score (vdHmTSS) in the overall population at Week 16
Description
The degree of joint damage is to be assessed using the vdHmTSS as used in the evaluation of Psoriatic Arthritis (PsA) compared to Baseline. This methodology quantifies the extent of joint erosions and joint space narrowing for 64 and 52 joints, respectively, with higher scores representing greater damage.
Time Frame
Baseline, Week 16
Title
American College of Rheumatology (ACR) 70 response at Week 16
Description
The ACR70 response rate is based on a 70% or greater improvement of arthritis relative to Baseline.
Time Frame
Week 16
Title
Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 4 in the subset of subjects with psoriatic skin lesions at Baseline
Description
Investigator Global Assessment (IGA) response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.
Time Frame
Baseline, Week 4
Title
Investigator Global Assessment (IGA) response defined as score of 0 (clear) or 1 (almost clear) AND at least a 2-grade reduction from Baseline at Week 16 in the subset of subjects with psoriatic skin lesions at Baseline
Description
Investigator Global Assessment (IGA) response is defined as Clear or Almost Clear with at least a 2-category improvement relative to Baseline.
Time Frame
Baseline, Week 16
Title
Change from Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16: PtAAP Visual Analog Scale (VAS)
Description
The PtAAP Visual Analog Scale (VAS) or 'Pain VAS' is part of the American College of Rheumatology (ACR) core set of measures in arthritis. Subjects will assess their arthritis pain using a VAS where 0 is "no pain" and 100 is "most severe pain."
Time Frame
Baseline, Week 16
Title
Enthesitis-free state based on the Spondyloarthritis Research Consortium of Canada (SPARCC) index at Week 16 in the subgroup of subjects with enthesitis at Baseline
Description
Presence of enthesitis will be assessed in the subgroup of subjects with enthesitis at Baseline. The SPARCC is an index that measures the severity of enthesitis through the assessment of 16 sites. Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, for an overall score range of 0 to 16.
Time Frame
Baseline, Week 16
Title
Change from Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) total score at Week 16
Description
The PsAID-12 total score is a patient-reported outcome measure for assessing the impact of Psoriatic Arthritis (PsA) in 12 physical and psychological domains, including pain, fatigue, skin problems, work and/or leisure activities, functional capacity, discomfort, sleep disturbance, coping, anxiety/fear/uncertainty, embarrassment and/or shame, social participation, and depression. Each domain is assessed with a single question using a 0 to 10 numerical rating scale. Each domain score is multiplied by a weighting factor and the results are then summed to provide the total score. The total score ranges from 0 to 10, with higher scores indicating a worse status. A score below 4 out of 10 is considered a patient-acceptable status. A change of 3 or more points is considered relevant absolute change.
Time Frame
Baseline, Week 16
Title
Incidence of treatment-emergent adverse events (TEAEs) during the study
Description
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time Frame
From Baseline until Safety Follow-Up (up to Week 72)
Title
Incidence of treatment-emergent serious adverse events (SAEs) during the study
Description
A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
Results in death
Is life-threatening
Requires in patient hospitalization or prolongation of existing hospitalization
Is a congenital anomaly or birth defect
Is an infection that requires treatment parenteral antibiotics
Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Time Frame
From Baseline until Safety Follow-Up (up to Week 72)
Title
Incidence of treatment-emergent adverse events (TEAEs) leading to withdrawal from investigational medicinal product (IMP) during the study
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time Frame
From Baseline until Safety Follow-Up (up to Week 72)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject
Subject is male or female at least 18 years of age
Female subject must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) >=3 out of 68 and swollen joint count (SJC) >=3 out of 66
Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies
Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO)
Subject must be a suitable candidate for treatment with adalimumab and has no contraindications to receive adalimumab as per the local label as assessed by the Investigator
Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry
Exclusion Criteria:
Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
Subjects with current or prior exposure to any biologics for the treatment of Psoriatic Arthritis (PsA) or Psoriasis (PSO)
Subject has an active infection or a history of recent serious infections
Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
Subject has a diagnosis of inflammatory conditions other than PSO or PsA. Subjects with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease at Screening or Baseline
Subject had acute anterior uveitis within 6 weeks of Baseline
Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and guttate PSO, or drug-induced PSO)
Presence of active suicidal ideation, or moderately severe major depression or severe major depression
Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273
Official's Role
Study Director
Facility Information:
Facility Name
Pa0010 50017
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85037
Country
United States
Facility Name
Pa0010 50035
City
San Diego
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Pa0010 50004
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Pa0010 50033
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Pa0010 50037
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Pa0010 50039
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Pa0010 50028
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Pa0010 50015
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
Facility Name
Pa0010 50016
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Pa0010 50029
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Pa0010 50010
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Pa0010 50125
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Pa0010 50040
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Pa0010 50020
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Pa0010 50006
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Pa0010 50008
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Pa0010 50007
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Pa0010 50001
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Pa0010 50012
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Pa0010 50002
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Pa0010 50049
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Pa0010 50051
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Pa0010 50036
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Pa0010 50009
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Facility Name
Pa0010 50050
City
Beckley
State/Province
West Virginia
ZIP/Postal Code
25801
Country
United States
Facility Name
Pa0010 30005
City
Camberwell
Country
Australia
Facility Name
Pa0010 30002
City
Clayton
Country
Australia
Facility Name
Pa0010 30008
City
Hobart
Country
Australia
Facility Name
Pa0010 30003
City
Maroochydore
Country
Australia
Facility Name
Pa0010 30007
City
Victoria Park
Country
Australia
Facility Name
Pa0010 30006
City
Woodville
Country
Australia
Facility Name
Pa0010 40003
City
Genk
Country
Belgium
Facility Name
Pa0010 40002
City
Leuven
Country
Belgium
Facility Name
Pa0010 40059
City
Mons
Country
Belgium
Facility Name
Pa0010 50041
City
Québec City
Country
Canada
Facility Name
Pa0010 50042
City
Rimouski
Country
Canada
Facility Name
Pa0010 50043
City
Sidney
Country
Canada
Facility Name
Pa0010 50044
City
Trois-Rivières
Country
Canada
Facility Name
Pa0010 40061
City
Brno
Country
Czechia
Facility Name
Pa0010 40065
City
Brno
Country
Czechia
Facility Name
Pa0010 40062
City
Ostrava
Country
Czechia
Facility Name
Pa0010 40009
City
Pardubice
Country
Czechia
Facility Name
Pa0010 40013
City
Praha 11
Country
Czechia
Facility Name
Pa0010 40066
City
Praha 2
Country
Czechia
Facility Name
Pa0010 40014
City
Praha 4
Country
Czechia
Facility Name
Pa0010 40063
City
Praha 5
Country
Czechia
Facility Name
Pa0010 40015
City
Praha
Country
Czechia
Facility Name
Pa0010 40010
City
Uherské Hradiště
Country
Czechia
Facility Name
Pa0010 40012
City
Zlín
Country
Czechia
Facility Name
Pa0010 40019
City
Paris
Country
France
Facility Name
Pa0010 40068
City
Tours
Country
France
Facility Name
Pa0010 40074
City
Bad Doberan
Country
Germany
Facility Name
Pa0010 40025
City
Berlin
Country
Germany
Facility Name
Pa0010 40028
City
Berlin
Country
Germany
Facility Name
Pa0010 40076
City
Cottbus
Country
Germany
Facility Name
Pa0010 40023
City
Erlangen
Country
Germany
Facility Name
Pa0010 40117
City
Frankfurt
Country
Germany
Facility Name
Pa0010 40029
City
Hamburg
Country
Germany
Facility Name
Pa0010 40071
City
Hamburg
Country
Germany
Facility Name
Pa0010 40027
City
Herne
Country
Germany
Facility Name
Pa0010 40078
City
Leipzig
Country
Germany
Facility Name
Pa0010 40348
City
Magdeburg
Country
Germany
Facility Name
Pa0010 40026
City
Ratingen
Country
Germany
Facility Name
Pa0010 40081
City
Budapest
Country
Hungary
Facility Name
Pa0010 40083
City
Budapest
Country
Hungary
Facility Name
Pa0010 40032
City
Debrecen
Country
Hungary
Facility Name
Pa0010 40030
City
Eger
Country
Hungary
Facility Name
Pa0010 40082
City
Kistarcsa
Country
Hungary
Facility Name
Pa0010 40079
City
Szentes
Country
Hungary
Facility Name
Pa0010 40080
City
Szombathely
Country
Hungary
Facility Name
Pa0010 40033
City
Székesfehérvár
Country
Hungary
Facility Name
Pa0010 40084
City
Catania
Country
Italy
Facility Name
Pa0010 40087
City
Milano
Country
Italy
Facility Name
Pa0010 40085
City
Pisa
Country
Italy
Facility Name
Pa0010 40086
City
Reggio Emilia
Country
Italy
Facility Name
Pa0010 20035
City
Bunkyō-Ku
Country
Japan
Facility Name
Pa0010 20043
City
Itabashi
Country
Japan
Facility Name
Pa0010 20036
City
Kawachi-Nagano-shi
Country
Japan
Facility Name
Pa0010 20049
City
Kitakyushu
Country
Japan
Facility Name
Pa0010 20045
City
Kita
Country
Japan
Facility Name
Pa0010 20044
City
Minato-Ku
Country
Japan
Facility Name
Pa0010 20033
City
Nagoya
Country
Japan
Facility Name
Pa0010 20041
City
Osaka
Country
Japan
Facility Name
Pa0010 20046
City
Osaka
Country
Japan
Facility Name
Pa0010 20048
City
Saitama
Country
Japan
Facility Name
Pa0010 20031
City
Sapporo-City
Country
Japan
Facility Name
Pa0010 20042
City
Sasebo
Country
Japan
Facility Name
Pa0010 20032
City
Suita
Country
Japan
Facility Name
Pa0010 20030
City
Tokyo
Country
Japan
Facility Name
Pa0010 40093
City
Białystok
Country
Poland
Facility Name
Pa0010 40119
City
Bydgoszcz
Country
Poland
Facility Name
Pa0010 40038
City
Elbląg
Country
Poland
Facility Name
Pa0010 40088
City
Elbląg
Country
Poland
Facility Name
Pa0010 40096
City
Gdynia
Country
Poland
Facility Name
Pa0010 40042
City
Kraków
Country
Poland
Facility Name
Pa0010 40092
City
Kraków
Country
Poland
Facility Name
Pa0010 40037
City
Lublin
Country
Poland
Facility Name
Pa0010 40091
City
Nowa Sól
Country
Poland
Facility Name
Pa0010 40044
City
Poznań
Country
Poland
Facility Name
Pa0010 40090
City
Poznań
Country
Poland
Facility Name
Pa0010 40118
City
Toruń
Country
Poland
Facility Name
Pa0010 40041
City
Warszawa
Country
Poland
Facility Name
Pa0010 40094
City
Warszawa
Country
Poland
Facility Name
Pa0010 40097
City
Warszawa
Country
Poland
Facility Name
Pa0010 40098
City
Warszawa
Country
Poland
Facility Name
Pa0010 40039
City
Wrocław
Country
Poland
Facility Name
Pa0010 40043
City
Wrocław
Country
Poland
Facility Name
Pa0010 40095
City
Wrocław
Country
Poland
Facility Name
Pa0010 20002
City
Moscow
Country
Russian Federation
Facility Name
Pa0010 20005
City
Moscow
Country
Russian Federation
Facility Name
Pa0010 20010
City
Moscow
Country
Russian Federation
Facility Name
Pa0010 20017
City
Moscow
Country
Russian Federation
Facility Name
Pa0010 20013
City
Petrozavodsk
Country
Russian Federation
Facility Name
Pa0010 20012
City
Ryazan'
Country
Russian Federation
Facility Name
Pa0010 20016
City
Ryazan'
Country
Russian Federation
Facility Name
Pa0010 20001
City
Saint Petersburg
Country
Russian Federation
Facility Name
Pa0010 20003
City
Saint Petersburg
Country
Russian Federation
Facility Name
Pa0010 20004
City
Saint Petersburg
Country
Russian Federation
Facility Name
Pa0010 20009
City
Saint Petersburg
Country
Russian Federation
Facility Name
Pa0010 20083
City
Saint Petersburg
Country
Russian Federation
Facility Name
Pa0010 20007
City
Saratov
Country
Russian Federation
Facility Name
Pa0010 20014
City
Ulyanovsk
Country
Russian Federation
Facility Name
Pa0010 20006
City
Vladimir
Country
Russian Federation
Facility Name
Pa0010 20008
City
Yaroslavl
Country
Russian Federation
Facility Name
Pa0010 20015
City
Yaroslavl
Country
Russian Federation
Facility Name
Pa0010 40045
City
Coruña
Country
Spain
Facility Name
Pa0010 40105
City
Córdoba
Country
Spain
Facility Name
Pa0010 40102
City
Málaga
Country
Spain
Facility Name
Pa0010 40101
City
Sabadell
Country
Spain
Facility Name
Pa0010 40104
City
Santiago De Compostela
Country
Spain
Facility Name
Pa0010 40049
City
Sevilla
Country
Spain
Facility Name
Pa0010 40103
City
Sevilla
Country
Spain
Facility Name
Pa0010 40106
City
Sevilla
Country
Spain
Facility Name
Pa0010 40099
City
Vigo
Country
Spain
Facility Name
Pa0010 40111
City
Leeds
Country
United Kingdom
Facility Name
Pa0010 40107
City
Wolverhampton
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
IPD Sharing Time Frame
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
IPD Sharing Access Criteria
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
IPD Sharing URL
http://www.Vivli.org
Citations:
PubMed Identifier
37696588
Citation
Ritchlin CT, Coates LC, McInnes IB, Mease PJ, Merola JF, Tanaka Y, Asahina A, Gossec L, Gottlieb AB, Warren RB, Ink B, Bajracharya R, Shende V, Coarse J, Landewe RB. Bimekizumab treatment in biologic DMARD-naive patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study. Ann Rheum Dis. 2023 Sep 11:ard-2023-224431. doi: 10.1136/ard-2023-224431. Online ahead of print.
Results Reference
result
Learn more about this trial
A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
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