Badanie oceniające skuteczność i bezpieczeństwo bimekizumabu w leczeniu pacjentów z czynnym łuszczycowym zapaleniem stawów (BE OPTIMAL)
Wieloośrodkowe, randomizowane, podwójnie zaślepione, kontrolowane placebo, aktywne badanie referencyjne (adalimumab) fazy 3 oceniające skuteczność i bezpieczeństwo bimekizumabu w leczeniu pacjentów z czynnym łuszczycowym zapaleniem stawów
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).
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
-
-
-
Camberwell, Australia
- Pa0010 30005
-
Clayton, Australia
- Pa0010 30002
-
Hobart, Australia
- Pa0010 30008
-
Maroochydore, Australia
- Pa0010 30003
-
Victoria Park, Australia
- Pa0010 30007
-
Woodville, Australia
- Pa0010 30006
-
-
-
-
-
Genk, Belgia
- Pa0010 40003
-
Leuven, Belgia
- Pa0010 40002
-
Mons, Belgia
- Pa0010 40059
-
-
-
-
-
Brno, Czechy
- Pa0010 40061
-
Brno, Czechy
- Pa0010 40065
-
Ostrava, Czechy
- Pa0010 40062
-
Pardubice, Czechy
- Pa0010 40009
-
Prague, Czechy
- Pa0010 40013
-
Prague, Czechy
- Pa0010 40014
-
Prague, Czechy
- Pa0010 40015
-
Prague, Czechy
- Pa0010 40063
-
Prague, Czechy
- Pa0010 40066
-
Uherské Hradiště, Czechy
- Pa0010 40010
-
Zlín, Czechy
- Pa0010 40012
-
-
-
-
-
Paris, Francja
- Pa0010 40019
-
Tours, Francja
- Pa0010 40068
-
-
-
-
-
A Coruña, Hiszpania
- Pa0010 40045
-
Córdoba, Hiszpania
- Pa0010 40105
-
Málaga, Hiszpania
- Pa0010 40102
-
Sabadell, Hiszpania
- Pa0010 40101
-
Santiago de Compostela, Hiszpania
- Pa0010 40104
-
Seville, Hiszpania
- Pa0010 40049
-
Seville, Hiszpania
- Pa0010 40103
-
Seville, Hiszpania
- Pa0010 40106
-
Vigo, Hiszpania
- Pa0010 40099
-
-
-
-
-
Bunkyō City, Japonia
- Pa0010 20035
-
Kawachi-Nagano-shi, Japonia
- Pa0010 20036
-
Kita-ku, Japonia
- Pa0010 20045
-
Kitakyushu, Japonia
- Pa0010 20049
-
Minatoku, Japonia
- Pa0010 20044
-
Nagoya, Japonia
- Pa0010 20033
-
Osaka, Japonia
- Pa0010 20041
-
Osaka, Japonia
- Pa0010 20046
-
Saitama, Japonia
- Pa0010 20048
-
Sapporo, Japonia
- Pa0010 20031
-
Sasebo, Japonia
- Pa0010 20042
-
Suita, Japonia
- Pa0010 20032
-
Tokyo, Japonia
- Pa0010 20030
-
tabashi City, Japonia
- Pa0010 20043
-
-
-
-
-
Québec, Kanada
- Pa0010 50041
-
Rimouski, Kanada
- Pa0010 50042
-
Sidney, Kanada
- Pa0010 50043
-
Trois-Rivières, Kanada
- Pa0010 50044
-
-
-
-
-
Bad Doberan, Niemcy
- Pa0010 40074
-
Berlin, Niemcy
- Pa0010 40025
-
Berlin, Niemcy
- Pa0010 40028
-
Cottbus, Niemcy
- Pa0010 40076
-
Erlangen, Niemcy
- Pa0010 40023
-
Frankfurt, Niemcy
- Pa0010 40117
-
Hamburg, Niemcy
- Pa0010 40029
-
Hamburg, Niemcy
- Pa0010 40071
-
Herne, Niemcy
- Pa0010 40027
-
Leipzig, Niemcy
- Pa0010 40078
-
Magdeburg, Niemcy
- Pa0010 40348
-
Ratingen, Niemcy
- Pa0010 40026
-
-
-
-
-
Bialystok, Polska
- Pa0010 40093
-
Bydgoszcz, Polska
- Pa0010 40119
-
Elblag, Polska
- Pa0010 40038
-
Elblag, Polska
- Pa0010 40088
-
Gdynia, Polska
- Pa0010 40096
-
Krakow, Polska
- Pa0010 40042
-
Krakow, Polska
- Pa0010 40092
-
Lublin, Polska
- Pa0010 40037
-
Nowa Sól, Polska
- Pa0010 40091
-
Poznan, Polska
- Pa0010 40044
-
Poznan, Polska
- Pa0010 40090
-
Torun, Polska
- Pa0010 40118
-
Warsaw, Polska
- Pa0010 40041
-
Warsaw, Polska
- Pa0010 40094
-
Warsaw, Polska
- Pa0010 40097
-
Warsaw, Polska
- Pa0010 40098
-
Wroclaw, Polska
- Pa0010 40039
-
Wroclaw, Polska
- Pa0010 40043
-
Wroclaw, Polska
- Pa0010 40095
-
-
-
-
-
Moscow, Rosja
- Pa0010 20002
-
Moscow, Rosja
- Pa0010 20005
-
Moscow, Rosja
- Pa0010 20010
-
Moscow, Rosja
- Pa0010 20017
-
Petrozavodsk, Rosja
- Pa0010 20013
-
Ryazan, Rosja
- Pa0010 20012
-
Ryazan, Rosja
- Pa0010 20016
-
Saint Petersburg, Rosja
- Pa0010 20001
-
Saint Petersburg, Rosja
- Pa0010 20003
-
Saint Petersburg, Rosja
- Pa0010 20004
-
Saint Petersburg, Rosja
- Pa0010 20009
-
Saint Petersburg, Rosja
- Pa0010 20083
-
Saratov, Rosja
- Pa0010 20007
-
Ulyanovsk, Rosja
- Pa0010 20014
-
Vladimir, Rosja
- Pa0010 20006
-
Yaroslavl, Rosja
- Pa0010 20008
-
Yaroslavl, Rosja
- Pa0010 20015
-
-
-
-
Arizona
-
Phoenix, Arizona, Stany Zjednoczone, 85037
- Pa0010 50017
-
-
California
-
San Diego, California, Stany Zjednoczone, 92025
- Pa0010 50035
-
Tustin, California, Stany Zjednoczone, 92780
- Pa0010 50004
-
-
Florida
-
Palm Harbor, Florida, Stany Zjednoczone, 34684
- Pa0010 50033
-
Tampa, Florida, Stany Zjednoczone, 33613
- Pa0010 50037
-
-
Georgia
-
Atlanta, Georgia, Stany Zjednoczone, 30342
- Pa0010 50039
-
-
Kentucky
-
Lexington, Kentucky, Stany Zjednoczone, 40504
- Pa0010 50028
-
-
Maryland
-
Hagerstown, Maryland, Stany Zjednoczone, 21742
- Pa0010 50015
-
-
Missouri
-
St Louis, Missouri, Stany Zjednoczone, 63141
- Pa0010 50016
-
-
New Mexico
-
Albuquerque, New Mexico, Stany Zjednoczone, 87102
- Pa0010 50029
-
-
New York
-
Brooklyn, New York, Stany Zjednoczone, 11201
- Pa0010 50010
-
-
North Carolina
-
Charlotte, North Carolina, Stany Zjednoczone, 28210
- Pa0010 50125
-
-
Ohio
-
Dayton, Ohio, Stany Zjednoczone, 45417
- Pa0010 50040
-
-
Pennsylvania
-
Duncansville, Pennsylvania, Stany Zjednoczone, 16635
- Pa0010 50020
-
Wyomissing, Pennsylvania, Stany Zjednoczone, 19610
- Pa0010 50006
-
-
Rhode Island
-
Johnston, Rhode Island, Stany Zjednoczone, 02919
- Pa0010 50008
-
-
South Carolina
-
Orangeburg, South Carolina, Stany Zjednoczone, 29118
- Pa0010 50007
-
-
Tennessee
-
Jackson, Tennessee, Stany Zjednoczone, 38305
- Pa0010 50001
-
Memphis, Tennessee, Stany Zjednoczone, 38119
- Pa0010 50012
-
-
Texas
-
Austin, Texas, Stany Zjednoczone, 78731
- Pa0010 50002
-
Corpus Christi, Texas, Stany Zjednoczone, 78404
- Pa0010 50049
-
Houston, Texas, Stany Zjednoczone, 77034
- Pa0010 50051
-
Mesquite, Texas, Stany Zjednoczone, 75150
- Pa0010 50036
-
Waco, Texas, Stany Zjednoczone, 76710
- Pa0010 50009
-
-
West Virginia
-
Beckley, West Virginia, Stany Zjednoczone, 25801
- Pa0010 50050
-
-
-
-
-
Budapest, Węgry
- Pa0010 40081
-
Budapest, Węgry
- Pa0010 40083
-
Debrecen, Węgry
- Pa0010 40032
-
Eger, Węgry
- Pa0010 40030
-
Kistarcsa, Węgry
- Pa0010 40082
-
Szentes, Węgry
- Pa0010 40079
-
Szombathely, Węgry
- Pa0010 40080
-
Székesfehérvár, Węgry
- Pa0010 40033
-
-
-
-
-
Catania, Włochy
- Pa0010 40084
-
Milan, Włochy
- Pa0010 40087
-
Pisa, Włochy
- Pa0010 40085
-
Reggio Emilia, Włochy
- Pa0010 40086
-
-
-
-
-
Leeds, Zjednoczone Królestwo
- Pa0010 40111
-
Wolverhampton, Zjednoczone Królestwo
- Pa0010 40107
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Bimekzumab dosage regimen
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 will receive bimekizumab at pre-specified time-points.
Inne nazwy:
Subjects will receive placebo at pre-specified time-points.
Inne nazwy:
|
|
Aktywny komparator: Adalimumab dosage regimen
Subjects randomized to this arm will receive the assigned adalimumab dosage regimen during the Treatment Period. |
Adalimumab will be administered according to the labeling recommendations.
Inne nazwy:
|
|
Komparator placebo: Placebo
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. |
Subjects will receive bimekizumab at pre-specified time-points.
Inne nazwy:
Subjects will receive placebo at pre-specified time-points.
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 16
Ramy czasowe: Week 16
|
ACR50 response rate: 50% or greater improvement of arthritis relative to Baseline. Those who met following 3 conditions for improvement from Baseline were classified as meeting ACR50 response criteria: greater than or equal (≥) 50% improvement in 68-tender joint count; ≥ 50% improvement in 66-swollen joint count; ≥ 50% improvement in at least 3 of 5 following parameters: Physician global assessment of disease activity (0-100 millimeter [mm] visual analog scale [VAS] [0 = no symptoms;100 = severe symptoms]), Patient global assessment of disease activity (100 mm VAS [0 = no limitation of normal activities; 100 = very poor]), Patient assessment of pain (100 mm VAS [0 = no pain; 100 = most severe pain]), Health Assessment Questionnaire-Disability Index (HAQ-DI) assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, lower scores indicated less disability and high-sensitivity C-reactive protein (hsCRP). |
Week 16
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16 for Placebo and BKZ
Ramy czasowe: Baseline, Week 16
|
The HAQ-DI contains 20 items that measured the degree of difficulty experienced in the following 8 categories of the daily living activities: dressing and grooming (2 items), arising (2 items), eating (3 items), walking (2 items), hygiene (3 items), reach (2 items), grip (3 items), and common daily activities (3 items). Each question was scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). The overall HAQ-DI total score was calculated by dividing the sum of the highest category scores (0 to 24) by the number of categories with at least 1 question answered. The HAQ-DI total score ranges from 0 (no difficulty) to 3 (maximum difficulty). A lower HAQ-DI score indicated an improvement in function. Change from baseline was computed as the value at Week 16 minus the baseline value. A negative value in change from baseline indicated an improvement. |
Baseline, Week 16
|
|
Percentage of Participants With a Psoriasis Area Severity Index (PASI) 90 Response at Week 4 in the Subgroup of Participants With Psoriasis (PSO) Involving at Least 3% Body Surface Area (BSA) at Baseline
Ramy czasowe: Baseline, Week 4
|
The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for 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 respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0 = no disease, the maximum score is 72 = maximal disease. |
Baseline, Week 4
|
|
Percentage of Participants With a PASI90 Response at Week 16 in the Subgroup of Participants With PSO Involving at Least 3% BSA at Baseline
Ramy czasowe: Baseline, Week 16
|
The PASI90 response assessments are based on at least 90% improvement in PASI score from Baseline. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for 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 respective section, and weighted by the percentage of the person's affected skin for respective section. The minimum possible PASI score is 0 = no disease, the maximum score is 72 = maximal disease. |
Baseline, Week 16
|
|
Change From Baseline in the Short Form 36-item Health Survey (SF-36) Physical Component Summary (PCS) at Week 16 for Placebo and BKZ
Ramy czasowe: Baseline, Week 16
|
SF-36 (version 2, standard recall):36-item generic health-related Quality of Life instrument that uses recall period of 4 weeks. Questionnaire has 36 questions composing scale that represent 8 domains:physical functioning; role physical; bodily pain;general health;vitality; social functioning;role emotional; and mental health. Scores for 8 domains were combined into two summary scores: physical component summary (PCS) score and mental component summary (MCS) score. Scores for 2 components summary (PCS and MCS) and 8 domains have been calculated and computed as raw/observed score to norm-based T-score metric(mean=50, standard deviation=10), raw score min=0(worst), max=100(best). Individual respondent's score falls outside T-score range of 45 to 55 was considered outside average range and when considering group-level data, score below 47 was considered indicative of impaired functioning within that health domain or dimension. Positive value in change from Baseline indicated improvement. |
Baseline, Week 16
|
|
Percentage of Participants With a Minimal Disease Activity (MDA) at Week 16
Ramy czasowe: Week 16
|
MDA is measure to indicate disease remission, and is based on composite score of 7 domains. Participant is considered having achieved MDA if participant fulfills at least 5 of following 7 criteria: Tender joint count (0-68 joints) less than or equal to (≤1); Swollen joint count (0-66 joints) ≤ 1; PASI ≤ 1 or BSA ≤ 3: In PASI, body divided into four parts, head and neck, upper limb, trunk and lower limbs. Each area assessed for erythema, induration and scaling, each rated on a scale of 0 to 4. Total score ranges from 0(no disease) to 72 (maximal disease)]; Patient's Assessment of Arthritis Pain ≤ 15 [using VAS on a scale of 0 (no pain) to 100 (severe pain)]; Patient's Global Assessment of Disease Activity ≤ 20 [using VAS on a scale of 0 (very well) to 100 (very poor)]; HAQ-DI score ≤ 0.5, HAQ-DI score ranges from 0 (no difficulty) to 3 (maximum difficulty); Leeds Enthesitis Index score ≤ 1 for participants with enthesitis at baseline. |
Week 16
|
|
Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdHmTSS) in Participants With Elevated Hs-CRP and/or at Least 1 Bone Erosion at Baseline at Week 16 for Placebo and BKZ
Ramy czasowe: Baseline, Week 16
|
The degree of joint damage was assessed using the vdHmTSS by quantifying the extent of bone erosions and joint space narrowing for 64 and 52 joints, respectively. The vdHmTSS ranges from 0 to 528, with higher scores representing greater damage. Descriptive statistics for ADA 40 mg reference arm was not calculated and reported since reference based imputation analysis method is used with Placebo as reference. As pre-specified in the SAP, this analysis was performed only for the participants randomized to Placebo and BKZ. |
Baseline, Week 16
|
|
Percentage of Participants With an Enthesitis-free State in the Leeds Enthesitis Index (LEI) at Week 16 in the Subgroup of Participants With Enthesitis at Baseline in the Pooled Population of PA0010 and PA0011
Ramy czasowe: Baseline of PA0010 for Participants of PA0010 and Baseline of PA0011 for Participants of PA0011, Week 16
|
Presence of enthesitis was assessed in the subgroup of participants 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 tenderness) and 1 (tenderness) at Baseline. The LEI consists of 6 items, 3 for the right part and 3 for the left part of the body. LEI is derived as the sum of the enthesitis score over the 6 sites mentioned above. The total score ranges from 0 to 6, higher scores indicates greater degree of enthesitis. Descriptive/Inferential statistics for ADA 40 mg reference arm was not calculated and reported since pooled data with PA0011 study is used which did not have ADA 40 mg arm. |
Baseline of PA0010 for Participants of PA0010 and Baseline of PA0011 for Participants of PA0011, Week 16
|
|
Percentage of Participants With a Dactylitis-free State Based on the Leeds Dactylitis Index (LDI) at Week 16 in the Subgroup of Participants With Dactylitis at Baseline in the Pooled Population of PA0010 and PA0011
Ramy czasowe: Baseline of PA0010 for Participants of PA0010 and Baseline of PA0011 for Participants of PA0011, Week 16
|
The LDI quantitatively measures dactylitis using the circumference of involved digits and control digits and tenderness of involved digits. Digits affected by dactylitis are defined as those with a 10% difference in the ratio of circumference of the affected digit to the contralateral digit. The control digit is either the contralateral digit (digit on opposite hand or foot). The ratio of circumference between an affected digit and the control digit is multiplied by the tenderness score for the affected digit. The results from each involved digit are summed to provide the final LDI score. A higher LDI indicates worse dactylitis. Tenderness score (0 = no tenderness, 1 = tender). Descriptive/Inferential statistics for ADA 40 mg reference arm was not calculated and reported since pooled data with PA0011 study was used which did not have ADA 40 mg arm. |
Baseline of PA0010 for Participants of PA0010 and Baseline of PA0011 for Participants of PA0011, Week 16
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 16
Ramy czasowe: Week 16
|
The ACR20 response rate was based on a 20% or greater improvement of arthritis relative to Baseline. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity (100 mm VAS [0 = no symptoms; 100 = severe symptoms]), Patient global assessment of disease activity (100 mm VAS [0 = no limitation of normal activities; 100 = very poor]), Patient assessment of pain (100 mm VAS [0 = no pain; 100 = most severe pain]), HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, lower scores indicated less disability, hsCRP. |
Week 16
|
|
Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdHmTSS) in the Overall Population at Week 16 for Placebo and BKZ
Ramy czasowe: Baseline, Week 16
|
The degree of joint damage was assessed using the vdHmTSS by quantifying the extent of bone erosions and joint space narrowing for 64 and 52 joints, respectively. The vdHmTSS ranges from 0 to 448, with higher scores representing greater damage. Descriptive statistics for ADA 40 mg reference arm was not calculated and reported since reference based imputation analysis method was used with Placebo as reference. |
Baseline, Week 16
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 70 Response at Week 16
Ramy czasowe: Week 16
|
The ACR70 response rate was based on a 70% or greater improvement of arthritis relative to Baseline. Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria: 1. ≥ 70% improvement in 68-tender joint count; 2. ≥ 70% improvement in 66-swollen joint count; and 3. ≥ 70% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity (100 mm VAS [0 = no symptoms;100 = severe symptoms]), Patient global assessment of disease activity (100 mm VAS [0 = no limitation of normal activities;100 = very poor]), Patient assessment of pain (100 mm VAS [0 = no pain; 100 = most severe pain]), HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, lower scores indicated less disability, hsCRP. |
Week 16
|
|
Percentage of Participants With 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 Participants With Psoriatic Skin Lesions at Baseline
Ramy czasowe: Baseline, Week 4
|
IGA measured the overall severity of PSO using the following 5-point scale and score was rated as 0 = clear (No signs of PSO; post-inflammatory hyperpigmentation may be present), 1 = almost clear (No thickening; normal to pink coloration; no to minimal focal scaling), 2 = mild (Just detectable to mild thickening; pink to light red coloration; predominately fine scaling), 3 = moderate (Clearly distinguishable to moderate thickening; dull to bright red, moderate scaling), and 4 = severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). The IGA response is defined as score of 0 (clear) or 1 (almost clear) with at least a 2-category improvement relative to Baseline. |
Baseline, Week 4
|
|
Percentage of Participants With an 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 Participants With Psoriatic Skin Lesions at Baseline
Ramy czasowe: Baseline, Week 16
|
IGA measured the overall severity of PSO using the following 5-point scale and score was rated as 0 = clear (No signs of PSO; post-inflammatory hyperpigmentation may be present), 1 = almost clear (No thickening; normal to pink coloration; no to minimal focal scaling), 2 = mild (Just detectable to mild thickening; pink to light red coloration; predominately fine scaling), 3 = moderate (Clearly distinguishable to moderate thickening; dull to bright red, moderate scaling), and 4 = severe (Severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions). The IGA response is defined as score of 0 (clear) or 1 (almost clear) with at least a 2-category improvement relative to Baseline. |
Baseline, Week 16
|
|
Change From Baseline in the Patient's Assessment of Arthritis Pain (PtAAP) at Week 16
Ramy czasowe: Baseline, Week 16
|
The PtAAP VAS is part of the American College of Rheumatology core set of measures in arthritis. Participants assessed their arthritis pain using a VAS ranging from 0 (no pain) to 100 (most severe pain). A negative change from baseline indicates improvement. |
Baseline, Week 16
|
|
Percentage of Participants With an Enthesitis-free State Based on the Spondyloarthritis Research Consortium of Canada (SPARCC) Index at Week 16 in the Subgroup of Participants With Enthesitis at Baseline
Ramy czasowe: Baseline, Week 16
|
Presence of enthesitis was assessed in the subgroup of participants with enthesitis at Baseline. The SPARCC index measures the severity of enthesitis through the assessment of 16 sites, 8 for the right part and 8 for the left part of the body: the greater trochanter (right/left), quadriceps tendon insertion into the patella (right/left), patellar ligament insertion into the patella and tibial tuberosity (right/left), achilles tendon insertion (right/left), plantar fascia insertion (right/left), medial and lateral epicondyles (right/left), and the supraspinatus insertion (right/left). Tenderness on examination is recorded as either present (1) or absent (0) for each of the 16 sites, for an average range of 0 (no enthesitis) to 16 (severe enthesitis). |
Baseline, Week 16
|
|
Change From Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) Total Score at Week 16
Ramy czasowe: Baseline, Week 16
|
The PsAID-12 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 was multiplied by a weighting factor and the results were then summed to provide the total score. The total score ranged from 0 to 10, with higher scores indicating a worse status. A negative change from baseline indicates improvement. |
Baseline, Week 16
|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
Ramy czasowe: From Baseline until Safety Follow-Up (up to Week 72)
|
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participants 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 (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. |
From Baseline until Safety Follow-Up (up to Week 72)
|
|
Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study
Ramy czasowe: From Baseline until Safety Follow-Up (up to Week 72)
|
A 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. TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. |
From Baseline until Safety Follow-Up (up to Week 72)
|
|
Percentage of Participants With TEAEs Leading to Withdrawal From IMP During the Study
Ramy czasowe: From Baseline until Safety Follow-Up (up to Week 72)
|
An AE is any untoward medical occurrence in a patient or clinical investigation participants 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 (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs were defined as any AEs with an onset date on or after the date of first IMP administration and within 140 days after the final dose of IMP. |
From Baseline until Safety Follow-Up (up to Week 72)
|
Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: UCB Cares, 001 844 599 2273
Publikacje i pomocne linki
Publikacje ogólne
- 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 Nov;82(11):1404-1414. doi: 10.1136/ard-2023-224431. Epub 2023 Sep 11.
- Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Secukinumab in Patients with Psoriatic Arthritis at 52 Weeks Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Jun;11(3):817-828. doi: 10.1007/s40744-024-00652-7. Epub 2024 Mar 6.
- Kristensen LE, Tillett W, Nash P, Coates LC, Mease PJ, Ogdie A, Gisondi P, Ink B, Prickett AR, Bajracharya R, Taieb V, Lyris N, Lambert J, Walsh JA. Association of achieving clinical disease control criteria and patient-reported outcomes in bimekizumab-treated patients with active psoriatic arthritis: results from two phase III studies. Ther Adv Musculoskelet Dis. 2024 Nov 11;16:1759720X241288071. doi: 10.1177/1759720X241288071. eCollection 2024.
- Mease PJ, Merola JF, Tanaka Y, Gossec L, McInnes IB, Ritchlin CT, Landewe RBM, Asahina A, Ink B, Heinrichs A, Bajracharya R, Shende V, Coarse J, Coates LC. Summary of Research: Safety and Efficacy of Bimekizumab in Patients with Psoriatic Arthritis: 2-Year Results from Two Phase 3 Studies. Rheumatol Ther. 2025 Aug;12(4):609-612. doi: 10.1007/s40744-025-00764-8. Epub 2025 May 10.
- Mease PJ, Gensler LS, Orbai AM, Warren RB, Bajracharya R, Ink B, Marten A, Massow U, Shende V, Manente M, Peterson L, White K, Landewe R, Poddubnyy D. Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies. RMD Open. 2025 Apr 6;11(2):e005026. doi: 10.1136/rmdopen-2024-005026.
- Mease PJ, Merola JF, Tanaka Y, Gossec L, McInnes IB, Ritchlin CT, Landewe RBM, Asahina A, Ink B, Heinrichs A, Bajracharya R, Shende V, Coarse J, Coates LC. Safety and Efficacy of Bimekizumab in Patients with Psoriatic Arthritis: 2-Year Results from Two Phase 3 Studies. Rheumatol Ther. 2024 Oct;11(5):1363-1382. doi: 10.1007/s40744-024-00708-8. Epub 2024 Aug 31.
- Warren RB, McInnes IB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, Mease PJ. Comparative Effectiveness of Bimekizumab and Guselkumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Jun;11(3):829-839. doi: 10.1007/s40744-024-00659-0. Epub 2024 Mar 15.
- Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Risankizumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Oct;11(5):1403-1412. doi: 10.1007/s40744-024-00706-w. Epub 2024 Aug 9.
- Gladman DD, Mease PJ, Gossec L, Husni ME, Gottlieb AB, Ink B, Bajracharya R, Coarse J, Lyris N, Lambert J, Tillett W. Effect of Bimekizumab on Patient-Reported Outcomes and Work Productivity in Patients With Psoriatic Arthritis: 1-Year Results From 2 Phase III Studies. J Rheumatol. 2025 May 1;52(5):466-478. doi: 10.3899/jrheum.2024-0923.
- Husni ME, Mease PJ, Merola JF, Tillett W, Goldammer N, Ink B, Coarse J, Lambert J, Taieb V, Gladman DD. Bimekizumab provided rapid improvements in patient-reported symptoms and health-related quality of life in patients with active psoriatic arthritis: pooled 16-week results from two phase 3 studies. RMD Open. 2024 Sep 23;10(3):e004464. doi: 10.1136/rmdopen-2024-004464.
- Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Ustekinumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Oct;11(5):1413-1423. doi: 10.1007/s40744-024-00705-x. Epub 2024 Aug 9.
- Gossec L, Orbai AM, de Wit M, Coates LC, Ogdie A, Ink B, Coarse J, Lambert J, Taieb V, Gladman DD. Effect of bimekizumab on patient-reported disease impact in patients with psoriatic arthritis: 1-year results from two phase 3 studies. Rheumatology (Oxford). 2024 Sep 1;63(9):2399-2410. doi: 10.1093/rheumatology/keae277.
- Maloney A, Dua P, Ahmed GF. Comparative Effectiveness of Bimekizumab in Psoriatic Arthritis: A Model-Based Meta-Analysis of American College of Rheumatology Response Criteria. Clin Pharmacol Ther. 2024 May;115(5):1007-1014. doi: 10.1002/cpt.3135. Epub 2024 Jan 12.
- McInnes IB, Asahina A, Coates LC, Landewe R, Merola JF, Ritchlin CT, Tanaka Y, Gossec L, Gottlieb AB, Warren RB, Ink B, Assudani D, Bajracharya R, Shende V, Coarse J, Mease PJ. Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). Lancet. 2023 Jan 7;401(10370):25-37. doi: 10.1016/S0140-6736(22)02302-9. Epub 2022 Dec 6.
- Mease PJ, Merola JF, Magrey M, Nash P, Poddubnyy D, Lebwohl M, Bajracharya R, Ink B, Marten A, Manente M, Peterson L, White K, Gensler LS. Bimekizumab longer-term safety profile in adult patients with axial spondyloarthritis or psoriatic arthritis: an updated analysis of six phase IIb/III clinical studies. RMD Open. 2026 Mar 10;12(1):e006174. doi: 10.1136/rmdopen-2025-006174.
- Thaci D, Asahina A, Boehncke WH, Gottlieb AB, Lebwohl M, Warren RB, Edens H, Ink B, Bajracharya R, Coarse J, Merola JF. Bimekizumab Efficacy and Safety in Patients with Psoriatic Arthritis with Substantial Skin and Nail Psoriasis to 1 Year. Dermatol Ther (Heidelb). 2026 Feb;16(2):953-976. doi: 10.1007/s13555-025-01599-5. Epub 2025 Dec 12.
- Gossec L, Coates LC, Landewe RBM, Mease PJ, Merola JF, Ritchlin CT, Tanaka Y, Asahina A, Proft F, Goldammer N, Manente M, Ink B, Bajracharya R, Coarse J, McInnes IB. Bimekizumab safety and efficacy in patients with psoriatic arthritis: 3-year results from two phase 3 studies. Rheumatology (Oxford). 2026 May 5;65(5):keag118. doi: 10.1093/rheumatology/keag118.
- Gossec L, Tillett W, Coates LC, Mease PJ, de Wit M, Gladman DD, Orbai AM, Proft F, Ink B, Bajracharya R, Lambert J, Healy P, Husni ME. Control of Inflammation and Sustained Improvements in Patient-Reported Outcomes in Patients With Psoriatic Arthritis: Bimekizumab Two-Year Results From Two Phase 3 Studies. ACR Open Rheumatol. 2026 May;8(5):e90053. doi: 10.1002/acr2.90053.
- Nikiphorou E, Tillett W, Deodhar A, Dubreuil M, Gossec L, Hwang M, Lubrano E, Machado PM, Rudwaleit M, de Wit M, Kavanagh S, de la Loge C, Ink B, Lambert J, Morup M, Boonen A, Walsh J. Effect of Bimekizumab Treatment on Health Status, Work Productivity, and Productivity Costs Through 3 Years in Axial Spondyloarthritis and Psoriatic Arthritis. J Rheumatol. 2026 Aug 1:jrheum.2026-0104. doi: 10.3899/jrheum.2026-0104. Online ahead of print.
- Deodhar A, Gottlieb AB, Merola JF, Soriano ER, Coates LC, Ink B, Bajracharya R, Healy P, Mease PJ. Bimekizumab efficacy across GRAPPA domains to 3 years in patients with psoriatic arthritis: a post hoc analysis of two phase 3 studies. Rheumatology (Oxford). 2026 Oct 10:keag557. doi: 10.1093/rheumatology/keag557. Online ahead of print.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby kości
- Choroby układu mięśniowo-szkieletowego
- Artretyzm
- Choroby stawów
- Choroby kręgosłupa
- Spondylartropatie
- Choroby skóry, grudkowo-łuskowate
- Choroby skórne
- Zapalenie stawów kręgosłupa
- Zapalenie stawów kręgosłupa
- Łuszczyca
- Choroby skóry i tkanki łącznej
- Zapalenie stawów, łuszczyca
- Aminokwasy, peptydy i białka
- Białka
- Przeciwciała, monoklonalne, humanizowane
- Przeciwciała, monoklonalne
- Przeciwciała
- Immunoglobuliny
- Immunoproteiny
- Białka krwi
- Globuliny w surowicy
- Globuliny
- Adalimumab
- Bimekizumab
Inne numery identyfikacyjne badania
- PA0010
- 2017 (Grant/umowa NIH USA)
- 2017-002322-20 (Numer EudraCT)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
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.
Ramy czasowe udostępniania IPD
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.
Kryteria dostępu do udostępniania IPD
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.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- CSR
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .