Clinical Trial Results:
A Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Multiple Doses of UCB4940 Administered as Add-on to Certolizumab Pegol Therapy in Subjects with Moderate-to-Severe Rheumatoid Arthritis
Summary
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EudraCT number |
2014-003307-30 |
Trial protocol |
HU SK CZ GB |
Global end of trial date |
19 Apr 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
04 May 2018
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First version publication date |
04 May 2018
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
RA0123
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02430909 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
UCB Celltech, UK Registered Branch of UCB Pharma SA
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Sponsor organisation address |
208 Bath Road, Slough, Berkshire, United Kingdom, SL1 3WE
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Public contact |
Clin Trial Reg & Results Disclosure, UCB Biosciences GmbH, clinicaltrials@ucb.com
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Scientific contact |
Clin Trial Reg & Results Disclosure, UCB Biosciences GmbH, clinicaltrials@ucb.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
06 Jun 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
19 Apr 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the safety and tolerability of bimekizumab (UCB4940) as an add-on therapy to certolizumab pegol (CZP) and background conventional disease-modifying anti-rheumatic drugs (DMARDs) compared to placebo plus CZP treatment and background conventional DMARDs and to evaluate the efficacy of bimekizumab as an add-on therapy to CZP and background conventional DMARDs compared to placebo plus CZP treatment and background conventional DMARDs at Week 20
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Protection of trial subjects |
During the conduct of the study all subjects were closely monitored.
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Background therapy |
Background therapy as permitted in the protocol. | ||
Evidence for comparator |
No | ||
Actual start date of recruitment |
05 May 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 1
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Country: Number of subjects enrolled |
Czech Republic: 2
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Country: Number of subjects enrolled |
Hungary: 15
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Country: Number of subjects enrolled |
Moldova, Republic of: 14
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Country: Number of subjects enrolled |
Poland: 54
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Country: Number of subjects enrolled |
Russian Federation: 73
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Worldwide total number of subjects |
159
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EEA total number of subjects |
72
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
138
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From 65 to 84 years |
21
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85 years and over |
0
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Recruitment
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Recruitment details |
The study started to enroll patients in May 2015 and concluded in April 2017. 288 subjects were included in the Screening Set. 129 subjects dropped screening and were excluded from the Safety Analysis Set. | ||||||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
The Participant Flow refers to the Safety Analysis Set which included all subjects who took at least 1 dose of study drug. | ||||||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Carer, Assessor | ||||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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CZP / CZP + PBO / CZP | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every 2 weeks) until Week 30 + Placebo from Week 8 to Week 18 | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Certolizumab pegol
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Investigational medicinal product code |
CZP
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion in pre-filled syringe
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Certolizumab pegol was supplied in prefilled syringes (PFS) containing a dosage strength of 200 mg/mL and given as a subcutaneous (sc) injection. CZP treatment started with a dosage of 400 mg at Weeks 0, 2, and 4, followed by 200 mg every 2 weeks from Week 6.
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Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Placebo was supplied as 0.9 % sodium chloride aqueous solution for intravenous infusion from Week 8 to Week 18 in order to maintain the blinding.
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Arm title
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CZP / CZP + BKZ / CZP | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every 2 weeks) until Week 30 + UCB4940 from Week 8 until Week 18 | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Bimekizumab
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Investigational medicinal product code |
UCB4940
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Active investigational product (infusion solution containing 80 mg/mL UCB4940) administered as intravenous (iv) infusion starting at Week 8 with a 240 mg loading dose followed by 120 mg every 2 weeks.
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Investigational medicinal product name |
Certolizumab pegol
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Investigational medicinal product code |
CZP
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion in pre-filled syringe
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Certolizumab pegol was supplied in prefilled syringes (PFS) containing a dosage strength of 200 mg/mL and given as a subcutaneous (sc) injection. CZP treatment started with a dosage of 400 mg at Weeks 0, 2, and 4, followed by 200 mg every 2 weeks from Week 6.
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Arm title
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CZP / CZP / CZP | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every 2 weeks) until Week 30 | ||||||||||||||||||||||||||||||||||||||||
Arm type |
only CZP | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Certolizumab pegol
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Investigational medicinal product code |
CZP
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion in pre-filled syringe
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Certolizumab pegol was supplied in prefilled syringes (PFS) containing a dosage strength of 200 mg/mL and given as a subcutaneous (sc) injection. CZP treatment started with a dosage of 400 mg at Weeks 0, 2, and 4, followed by 200 mg every 2 weeks from Week 6.
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Baseline characteristics reporting groups
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Reporting group title |
CZP / CZP + PBO / CZP
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Reporting group description |
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every 2 weeks) until Week 30 + Placebo from Week 8 to Week 18 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
CZP / CZP + BKZ / CZP
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Reporting group description |
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every 2 weeks) until Week 30 + UCB4940 from Week 8 until Week 18 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
CZP / CZP / CZP
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Reporting group description |
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every 2 weeks) until Week 30 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
CZP / CZP + PBO / CZP
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Reporting group description |
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every 2 weeks) until Week 30 + Placebo from Week 8 to Week 18 | ||
Reporting group title |
CZP / CZP + BKZ / CZP
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Reporting group description |
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every 2 weeks) until Week 30 + UCB4940 from Week 8 until Week 18 | ||
Reporting group title |
CZP / CZP / CZP
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Reporting group description |
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every 2 weeks) until Week 30 | ||
Subject analysis set title |
CZP / CZP + PBO / CZP-SS
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The Safety Set (SS) consisted of all subjects who received at least 1dose (full or partial) of any study medication. In the case of dosing administration error, analyses on the SS were conducted according to actual treatment received. The SS was used for the safety analyses. The safety analyses of the randomized subjects was conducted on the Safety Subset (SSsub) that was defined as all randomized subjects who received at least 1 dose (full or partial) of bimekizumab or placebo.
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Subject analysis set title |
CZP / CZP + BKZ / CZP-SS
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The Safety Set (SS) consisted of all subjects who received at least 1dose (full or partial) of any study medication. In the case of dosing administration error, analyses on the SS were conducted according to actual treatment received. The SS was used for the safety analyses. The safety analyses of the randomized subjects was conducted on the Safety Subset (SSsub) that was defined as all randomized subjects who received at least 1 dose (full or partial) of bimekizumab or placebo.
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Subject analysis set title |
CZP / CZP / CZP-SS
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The Safety Set (SS) consisted of all subjects who received at least 1dose (full or partial) of any study medication. In the case of dosing administration error, analyses on the SS were conducted according to actual treatment received. The SS was used for the safety analyses. The safety analyses of the randomized subjects was conducted on the Safety Subset (SSsub) that was defined as all randomized subjects who received at least 1 dose (full or partial) of bimekizumab or placebo.
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Subject analysis set title |
CZP / CZP + PBO / CZP-FAS
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose (full or partial) of any study medication and who had at least 1 available measurement of any efficacy variables post-Baseline 1.
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Subject analysis set title |
CZP / CZP + BKZ / CZP-FAS
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose (full or partial) of any study medication and who had at least 1 available measurement of any efficacy variables post-Baseline 1.
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Subject analysis set title |
CZP / CZP / CZP-FAS
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose (full or partial) of any study medication and who had at least 1 available measurement of any efficacy variables post-Baseline 1.
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End point title |
Incidence of Adverse Events [1] | ||||||||||||||||
End point description |
All adverse events (AEs) are recorded during the entire study period.
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End point type |
Primary
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End point timeframe |
From Baseline (Week 0) until final study visit (Week 44)
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
Change from Baseline 2 to Week 20 in DAS28(CRP) [2] | ||||||||||||
End point description |
DAS28 (Disease Activity Score 28) is a measure of disease activity in Rheumatoid Arthritis (RA) and is a composite score derived from the number of swollen and tender joints (out of 28), the CRP value and the patient global assessment of disease activity.
A negative value in Change from Baseline indicates an improvement from Baseline.
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End point type |
Primary
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End point timeframe |
Week 20
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The Bayesian model uses an informative prior distribution for the PBO+CZP group, vague priors for all other parameters. Fixed effect; treatment. Covariate; DAS28(CRP) at baseline 2. It is a pre-specified superiority analysis. 70 subjects were included in 2 comparison groups [CZP/CZP + PBO/CZP-FAS; CZP/CZP + BKZ/CZP-FAS]. The posterior probability of a difference from Placebo being greater than 0 was 99.4 %. Point estimate (Mean Difference (SD)): 0.58 (0.23); 95% Credible interval: [0.13, 1.05] |
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No statistical analyses for this end point |
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End point title |
Percent improvement in ACR (American College of Rheumatology) criteria (ACRn) based on Baseline 2 | ||||||||||||
End point description |
ACRn is the percentage improvement from Baseline 2 in the number of tender joints, in the number of swollen joints, and in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
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End point type |
Secondary
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End point timeframe |
Week 20
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No statistical analyses for this end point |
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End point title |
ACR20 response based on Baseline 2 | ||||||||||||
End point description |
The assessments are based on a 20 % or greater improvement from Baseline 2 in the number of tender joints, in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
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End point type |
Secondary
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End point timeframe |
Week 20
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No statistical analyses for this end point |
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End point title |
ACR50 response based on Baseline 2 | ||||||||||||
End point description |
The assessments are based on a 50 % or greater improvement from Baseline 2 in the number of tender joints, in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
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End point type |
Secondary
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End point timeframe |
Week 20
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No statistical analyses for this end point |
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End point title |
ACR70 response based on Baseline 2 | ||||||||||||
End point description |
The assessments are based on a 70 % or greater improvement from Baseline 2 in the number of tender joints, in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
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End point type |
Secondary
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End point timeframe |
Week 20
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No statistical analyses for this end point |
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End point title |
DAS28(CRP) remission at Week 20 | ||||||||||||||||
End point description |
DAS28(CRP) remission is defined as DAS28(CRP) < 2.6. DAS28 is a measure of disease activity in Rheumatoid Arthritis (RA) and is a composite score derived from the number of swollen and tender joints (out of 28) , the C-reactive protein value and the patient global assessment of disease activity.
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End point type |
Secondary
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End point timeframe |
Week 20
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse events were collected during the whole study from Study Start (Day 1) until Safety Follow-Up or Withdrawal Visit (up to Week 44)
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Adverse event reporting additional description |
For the incidence of Treatment-Emergent Adverse Events (TEAEs) by Relationship, related is defined as related to bimekizumab (BKZ)/placebo and/or related to certolizumab pegol (CZP).
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.0
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Reporting groups
|
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Reporting group title |
CZP / CZP + PBO / CZP
|
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Reporting group description |
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every 2 weeks) until Week 30 + Placebo from Week 8 to Week 18 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
CZP / CZP + BKZ / CZP
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Reporting group description |
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every 2 weeks) until Week 30 + UCB4940 from Week 8 until Week 18 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
CZP / CZP / CZP
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Reporting group description |
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every 2 weeks) until Week 30 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |