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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000957-37 | EudraCT Number |
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The purpose of the study is to evaluate the efficacy and safety of bimekizumab compared to certolizumab pegol in the treatment of subjects with active ankylosing spondylitis (AS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimekizumab | Experimental | Subjects will receive several bimekizumab administrations on pre-defined time points. Placebo will be provided in this arm to mask the certolizumab pegol loading dose. |
|
| Certolizumab pegol | Experimental | Subjects will receive several certolizumab pegol administrations on pre-defined time points. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimekizumab | Drug | One bimekizumab dose will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12 | ASDAS was calculated as the sum of the results from the following components: 0.121xTotal spinal pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 result), 0.058xDuration of morning stiffness (BASDAI Question 6 result), 0.110xPGADA, 0.073xPeripheral pain/swelling (BASDAI Question 3 result), 0.579x(natural logarithm of the CRP [mg/L] + 1), Spinal pain, PGADA, duration of morning stiffness, peripheral pain/swelling were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.980 for ASDAS (as a fixed value of 2 was assumed for values of hs-CRP below the LLOQ), but no defined upper score. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. Posterior means and 95% credible intervals in each group are presented. | From Baseline to Week 12 |
| Number of Participants With Adverse Events (AE) During the Study Conduct | An AE was any untoward medical occurrence in a patient or clinical investigation participant 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. A treatment-emergent adverse event (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP. | From Baseline until Safety Follow-Up Visit (up to Week 64) |
| Number of Participants With Serious Adverse Events (SAEs) During the Study Conduct | An SAE was any untoward medical occurrence that at any dose: - Resulted in death - Is life-threatening - Required in patient hospitalisation or prolongation of existing hospitalisation - Is a congenital anomaly or birth defect - Is an infection that requires treatment with parenteral antibiotics - Other important medical events which based on medical or scientific judgement may jeopardised the participants, or may require medical or surgical intervention to prevent any of the above. A TEAE was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Ankylosing Spondylitis Disease Activity Score - Inactive Disease (ASDAS-ID) at Week 12 | ASDAS-ID was defined by ASDAS < 1.3. ASDAS was calculated as the sum of the results from the following components: 0.121xTotal spinal pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 result), 0.058xDuration of morning stiffness (BASDAI Question 6 result), 0.110xPGADA, 0.073xPeripheral pain/swelling (BASDAI Question 3 result), 0.579x(natural logarithm of the CRP [mg/L] + 1), Spinal pain, PGADA, duration of morning stiffness, peripheral pain/swelling were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.980 for ASDAS (as a fixed value of 2 was assumed for values of hs-CRP below the LLOQ), but no defined upper score. |
Not provided
Inclusion Criteria:
Documented diagnosis of active adult-onset ankylosing spondylitis (AS) as defined by documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984) of at least 3 months' symptom duration and age of onset <45 years
Subject has moderate to severe active disease at the Screening Visit as defined by each of the following:
Subjects must have had an inadequate response to, have a contraindication to, or have been intolerant to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs)
Subjects taking corticosteroids must be on a maximum daily dose of <=10mg/day oral prednisolone or equivalent
Subjects taking methotrexate (MTX; <=25 mg/week) are allowed to continue their medication if they received a stable dose for at least 12 weeks before randomization
Subjects taking sulfasalazine (up to 3 grams/day) or hydroxychloroquine (up to 400 mg per day total) are allowed to continue their medication if started at least 12 weeks prior to randomization
Subject who has been on an anti-tumor necrosis factor alpha (TNFα) agent must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months or have been intolerant to at least 1 administration of an anti-TNFα agent. Subjects may not have been on more than 1 anti-TNFα agent
Subject has high-sensitive C-Reactive Protein (hsCRP) levels >=3 mg/L at the Screening Visit
Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of investigational medicinal product (IMP)
Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, up till 20 weeks after the last administration of IMP
Exclusion Criteria:
Subject has received previous or current biological treatment other than TNFα inhibitor treatment
Subjects with a total ankylosis of the spine, or a diagnosis of any other inflammatory arthritis eg, rheumatoid arthritis (RA), sarcoidosis, systemic lupus erythematosus, or reactive arthritis
Subjects with any current sign or symptom that may indicate an active infection (except for the common cold)
Subject has received previous or current biological treatment other than TNFα inhibitor treatment
Subject has chronic, recurrent, recent serious / life-threatening or current infection, as defined in the protocol
Subject has history of certain atypical infections, viral hepatitides, human immunodeficiency virus (HIV) infection, tuberculosis, as defined in the protocol
Subjects receiving any live vaccination within the 8 weeks prior to Baseline
Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, with latent TB infection or current or history of nontuberculous mycobacteria (NTMB) infection
Subject has immunosuppressive condition or treatment, recent history of malignancy (some exceptions) or demyelinating disease
Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be included:
Subject has history of psychiatric disorder, including suicidality (as defined in the protocol
Subject has major abnormalities on laboratory testing, as defined in the protocol
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | +1-844-599-2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| As0013 908 | Ormond Beach | Florida | 32174 | United States | ||
| As0013 903 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39620046 | Derived | Baraliakos X, de Jongh J, Poddubnyy D, Zwezerijnen GJC, Hemke R, Glatt S, Shaw S, Ionescu L, El Baghdady A, Mann J, Maguire RP, Vaux T, de Peyrecave N, Oortgiesen M, Baeten D, van der Laken C. Impact of bimekizumab and certolizumab pegol on efficacy, safety and osteoblastic activity in radiographic axial spondyloarthritis: results from a phase IIa, multicentre, randomised, double-blind, exploratory study with PET-CT imaging. Ther Adv Musculoskelet Dis. 2024 Nov 28;16:1759720X241293944. doi: 10.1177/1759720X241293944. eCollection 2024. |
| Label | URL |
|---|---|
| Product Information | View source |
Not provided
Data from this study 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 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.clinicalstudydatarequest.com 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 a determination is made that the data cannot be adequately anonymized.
Data from this study 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.
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.clinicalstudydatarequest.com 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.
The Participant Flow refers to the Randomized Set (RS).
The study started to enroll study participants in October 2017 and concluded in May 2020.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Certolizumab Pegol | Participants received certolizumab pegol (CZP) 400 milligrams (mg) subcutaneously (sc) every 2 weeks (Q2W) at Weeks 0, 2, and 4 (loading dose) followed by CZP 200 mg sc Q2W in Weeks 6 to 10 and 400 mg every 4 weeks (Q4W) from Week 12 to Week 44. |
| FG001 | Bimekizumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 27, 2019 | May 19, 2023 |
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This is an investigator-blind and subject-blind study.
| Certolizumab pegol | Drug | Two certolizumab pegol doses will be administered. One of these doses is a loading dose. |
|
|
| Placebo | Other | Placebo will be provided to maintain the blinding. |
|
| From Baseline until Safety Follow-Up Visit (up to Week 64) |
| Number of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Conduct | An AE was any untoward medical occurrence in a patient or clinical investigation participant 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. A TEAE was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP. | From Baseline until Safety Follow-Up Visit (up to Week 64) |
| Week 12 |
| Number of Participants With Ankylosing Spondylitis Disease Activity Score-Major Improvement (ASDAS-MI) at Week 12 | ASDAS-MI was defined by a reduction (improvement) from Baseline in ASDAS >=2 units. ASDAS was calculated as the sum of the results from the following components: 0.121xTotal spinal pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 result), 0.058xDuration of morning stiffness (BASDAI Question 6 result), 0.110xPGADA, 0.073xPeripheral pain/swelling (BASDAI Question 3 result), 0.579x(natural logarithm of the CRP [mg/L] + 1), Spinal pain, PGADA, duration of morning stiffness, peripheral pain/swelling were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.980 for ASDAS (as a fixed value of 2 was assumed for values of hs-CRP below the LLOQ), but no defined upper score. | Baseline, Week 12 |
| Lincoln |
| Nebraska |
| 68516 |
| United States |
| As0013 902 | Oklahoma City | Oklahoma | 73103 | United States |
| As0013 906 | Memphis | Tennessee | 38119 | United States |
| As0013 202 | Kladno | Czechia |
| As0013 205 | Ostrava | Czechia |
| As0013 201 | Prague | Czechia |
| As0013 203 | Prague | Czechia |
| As0013 302 | Berlin | Germany |
| As0013 306 | Berlin | Germany |
| As0013 304 | Erlangen | Germany |
| As0013 303 | Hamburg | Germany |
| As0013 301 | Herne | Germany |
| As0013 405 | Athens | Greece |
| As0013 404 | Heraklion | Greece |
| As0013 401 | Pátrai | Greece |
| As0013 402 | Thessaloniki | Greece |
| As0013 406 | Thessaloniki | Greece |
| As0013 501 | Chisinau | Moldova |
| As0013 601 | Amsterdam | Netherlands |
| As0013 708 | Bialystok | Poland |
| As0013 709 | Krakow | Poland |
| As0013 706 | Olsztyn | Poland |
| As0013 703 | Poznan | Poland |
| As0013 702 | Torun | Poland |
| As0013 701 | Warsaw | Poland |
| As0013 704 | Warsaw | Poland |
| As0013 707 | Wroclaw | Poland |
| As0013 801 | Kazan' | Russia |
| As0013 803 | Kemerovo | Russia |
| As0013 806 | Moscow | Russia |
| As0013 807 | Moscow | Russia |
| As0013 802 | Yaroslavl | Russia |
| As0013 805 | Yaroslavl | Russia |
| Product Information | View source |
| FDA Safety Alerts and Recalls | View source |
Participants received bimekizumab (BKZ) 160 mg sc Q2W from Week 0 through Week 10 and 320 mg sc Q4W from Week 12 to Week 44. In addition, participants received placebo injection to maintain the blind for the CZP loading dose at Baseline, Week 2 and Week 4. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Baseline Characteristics refer to Safety Set which consisted of all randomized study participants who received at least 1 dose (full or partial) of the investigational medicinal product (IMP).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Certolizumab Pegol | Participants received certolizumab pegol (CZP) 400 milligrams (mg) subcutaneously (sc) every 2 weeks (Q2W) at Weeks 0, 2, and 4 (loading dose) followed by CZP 200 mg sc Q2W in Weeks 6 to 10 and 400 mg every 4 weeks (Q4W) from Week 12 to Week 44. |
| BG001 | Bimekizumab | Participants received bimekizumab (BKZ) 160 mg sc Q2W from Week 0 through Week 10 and 320 mg sc Q4W from Week 12 to Week 44. In addition, participants received placebo injection to maintain the blind for the CZP loading dose at Baseline, Week 2 and Week 4. |
| BG002 | Total Title |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12 | ASDAS was calculated as the sum of the results from the following components: 0.121xTotal spinal pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 result), 0.058xDuration of morning stiffness (BASDAI Question 6 result), 0.110xPGADA, 0.073xPeripheral pain/swelling (BASDAI Question 3 result), 0.579x(natural logarithm of the CRP [mg/L] + 1), Spinal pain, PGADA, duration of morning stiffness, peripheral pain/swelling were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.980 for ASDAS (as a fixed value of 2 was assumed for values of hs-CRP below the LLOQ), but no defined upper score. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. Posterior means and 95% credible intervals in each group are presented. | Per Protocol Set (PPS) consisted of all study participants in the Full Analysis Set who had no important protocol deviation affecting the primary efficacy variable. Here, Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | 95% Confidence Interval | scores on a scale | From Baseline to Week 12 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events (AE) During the Study Conduct | An AE was any untoward medical occurrence in a patient or clinical investigation participant 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. A treatment-emergent adverse event (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP. | Safety Set (SS) consisted of all randomized study participants who received at least 1 dose (full or partial) of the IMP. | Posted | Count of Participants | Participants | From Baseline until Safety Follow-Up Visit (up to Week 64) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Serious Adverse Events (SAEs) During the Study Conduct | An SAE was any untoward medical occurrence that at any dose: - Resulted in death - Is life-threatening - Required in patient hospitalisation or prolongation of existing hospitalisation - Is a congenital anomaly or birth defect - Is an infection that requires treatment with parenteral antibiotics - Other important medical events which based on medical or scientific judgement may jeopardised the participants, or may require medical or surgical intervention to prevent any of the above. A TEAE was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP. | Safety Set (SS) consisted of all randomized study participants who received at least 1 dose (full or partial) of the IMP. | Posted | Count of Participants | Participants | From Baseline until Safety Follow-Up Visit (up to Week 64) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Conduct | An AE was any untoward medical occurrence in a patient or clinical investigation participant 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. A TEAE was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP. | Safety Set (SS) consisted of all randomized study participants who received at least 1 dose (full or partial) of the IMP. | Posted | Count of Participants | Participants | From Baseline until Safety Follow-Up Visit (up to Week 64) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Ankylosing Spondylitis Disease Activity Score - Inactive Disease (ASDAS-ID) at Week 12 | ASDAS-ID was defined by ASDAS < 1.3. ASDAS was calculated as the sum of the results from the following components: 0.121xTotal spinal pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 result), 0.058xDuration of morning stiffness (BASDAI Question 6 result), 0.110xPGADA, 0.073xPeripheral pain/swelling (BASDAI Question 3 result), 0.579x(natural logarithm of the CRP [mg/L] + 1), Spinal pain, PGADA, duration of morning stiffness, peripheral pain/swelling were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.980 for ASDAS (as a fixed value of 2 was assumed for values of hs-CRP below the LLOQ), but no defined upper score. | Per-Protocol Set (PPS) consisted of all study participants in the Full Analysis Set who had no important protocol deviation affecting the primary efficacy variable. Here, Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Ankylosing Spondylitis Disease Activity Score-Major Improvement (ASDAS-MI) at Week 12 | ASDAS-MI was defined by a reduction (improvement) from Baseline in ASDAS >=2 units. ASDAS was calculated as the sum of the results from the following components: 0.121xTotal spinal pain (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 result), 0.058xDuration of morning stiffness (BASDAI Question 6 result), 0.110xPGADA, 0.073xPeripheral pain/swelling (BASDAI Question 3 result), 0.579x(natural logarithm of the CRP [mg/L] + 1), Spinal pain, PGADA, duration of morning stiffness, peripheral pain/swelling were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.980 for ASDAS (as a fixed value of 2 was assumed for values of hs-CRP below the LLOQ), but no defined upper score. | Per-Protocol Set (PPS) consisted of all study participants in the Full Analysis Set who had no important protocol deviation affecting the primary efficacy variable. Here, Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline, Week 12 |
|
From Baseline until Safety Follow-Up Visit (up to Week 64)
A treatment-emergent adverse event (TEAE) was defined as any AE with a start date/time at the time of or after the first dose of IMP up until 140 days after the last dose of IMP.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Certolizumab Pegol (SS) | Participants received CZP 400 mg sc Q2W at Weeks 0, 2, and 4 (loading dose) followed by CZP 200 mg sc Q2W in Weeks 6 to 10 and 400 mg Q4W from Week 12 to Week 44. Participants formed the Safety Set (SS). | 1 | 25 | 3 | 25 | 16 | 25 |
| EG001 | Bimekizumab (SS) | Participants received BKZ 160 mg sc Q2W from Week 0 through Week 10 and 320 mg sc Q4W from Week 12 to Week 44. In addition, participants received placebo injection to maintain the blind for the CZP loading dose at Baseline, Week 2 and Week 4. Participants formed the SS. | 0 | 51 | 5 | 51 | 27 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery stenosis | Cardiac disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Traumatic arthritis | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA19.0 | Non-systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA19.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA19.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA19.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA19.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA19.0 | Non-systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA19.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA19.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | 001 844 599 2273 | UCBCares@ucb.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 19, 2020 | May 19, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
Not provided
Not provided
| ID | Term |
|---|---|
| C000625981 | bimekizumab |
| D000068582 | Certolizumab Pegol |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D007140 | Immunoglobulin Fab Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| >=65 years |
|
| Male |
|
Results were based on a complete case (ie, data as observed) Bayesian linear model with the change from Baseline in ASDAS as the independent variable. Treatment was included as a predictor in the model and Baseline ASDAS as a covariate. Pr[Diff>0%](%) refers to the probability that the mean change from Baseline in ASDAS in the BKZ group was greater than the mean change from Baseline in ASDAS in the CZP group. |
| Regression, Linear |
| PR[Diff > 0%](%) |
| 88.4 |
| 2-Sided |
| Superiority |
|
|
|
|
|
|
|
|
Participants received BKZ 160 mg sc Q2W from Week 0 through Week 10 and 320 mg sc Q4W from Week 12 to Week 44. In addition, participants received placebo injection to maintain the blind for the CZP loading dose at Baseline, Week 2 and Week 4. Participants formed the PPS.
|
|