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Pediatric Arthritis Study of Certolizumab Pegol (PASCAL)

Primary Purpose

Polyarticular-course Juvenile Idiopathic Arthritis (JIA)

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Certolizumab Pegol (CZP)
Certolizumab Pegol (CZP)
Sponsored by
UCB BIOSCIENCES GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polyarticular-course Juvenile Idiopathic Arthritis (JIA) focused on measuring Cimzia, JIA, Polyarticular, Oligoarticular, Enthesitis-related-Arthritis, Juvenile Idiopathic Arthritis, Juvenile Psoriatic Arthritis, Certolizumab Pegol, PASCAL, CDP870

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Study participant is 2 to 17 years of age (inclusive) at Baseline (Visit 2)
  • Study participants must weigh ≥10 kg (22lb) at Baseline (Visit 2)
  • Study participants must have had onset of signs and symptoms consistent with a diagnosis of Juvenile Idiopathic Arthritis (JIA) (according to the International League of Associations for Rheumatology Classification of Juvenile Idiopathic Arthritis, 2001) and initiation of JIA treatment for at least 6 months prior to Baseline (Visit 2). Eligible JIA categories include: polyarthritis rheumatoid factor-positive, polyarthritis rheumatoid factor-negative, extended oligoarthritis, juvenile psoriatic arthritis, and enthesitis-related arthritis (ERA)
  • Study participants must have active polyarticular-course disease, defined as ≥5 joints with active arthritis at Screening and at Baseline
  • Study participants must have had an inadequate response to, or intolerance to, at least 1 disease-modifying antirheumatic drug (DMARD) (nonbiologic or biologic). For example, study participant had prior inadequate response to methotrexate (MTX) (based on the Investigator's clinical judgment)
  • If the study participant is using MTX, then the study participant must have been on MTX for a minimum of 3 months at Screening. In addition, the dose must have been stable for at least 1 month before Screening at ≥10 to ≤15 mg/m^2 per week. If the study participant is not using MTX, then the treatment must have been previously withdrawn for documented reasons of intolerability or inadequate response
  • If the study participant is using oral corticosteroid therapy, the dose must have been stable for at least 7 days prior to the Baseline arthritis assessment at a maximum dose of 10 mg or 0.2 mg/kg prednisone (or equivalent) per day, whichever is the smaller dose

Exclusion Criteria:

  • Study participant has previously been exposed to more than 2 biologic agents
  • Study participant previously failed to respond to treatment with more than one tumor necrosis factor alpha (TNFα) antagonist drug
  • Study participant is currently receiving or has received any experimental (biological or nonbiological) therapy (within or outside a clinical study) in the 3 months or 5 half-lives prior to Baseline (Visit 2), whichever is longer
  • Study participant had previous treatment with a biological therapy for juvenile idiopathic arthritis (JIA) that resulted in a severe hypersensitivity reaction or an anaphylactic reaction
  • Study participant previously participated in this study or has previously been treated with CZP (whether in a study or not)
  • Study participant has a history of systemic JIA, with or without systemic features
  • Study participant has a secondary, noninflammatory type of rheumatic disease or of joint pains (eg, fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of study medication
  • Study participant has other inflammatory arthritis (eg, systemic lupus erythematosus, inflammatory bowel disease-related)
  • Study participant has active uveitis or a history of active uveitis within the preceding 6 months
  • Study participant has current, chronic or recurrent clinically significant infections
  • Study participant has a current sign or symptom which may indicate infection (eg, fever, cough), a history of chronic or recurrent infections within the same organ system (more than 3 episodes requiring antibiotics/antivirals during the 12 months prior to Screening [Visit 1]), had a recent (within the 6 months prior to Screening [Visit 1]) serious or life-threatening infection (including herpes zoster), or is at a high risk of infection in the Investigator's opinion (eg, study participants with leg ulcers, indwelling urinary catheter, and persistent or recurrent chest infections or permanently bed-ridden or wheelchair bound)

Sites / Locations

  • Ra0043 71
  • Ra0043 79
  • Ra0043 84
  • Ra0043 83
  • Ra0043 81
  • Ra0043 82
  • Ra0043 90
  • Ra0043 75
  • Ra0043 80
  • Ra0043 77
  • Ra0043 85
  • Ra0043 87
  • Ra0043 74
  • Ra0043 76
  • Ra0043 70
  • Ra0043 73
  • Ra0043 78
  • Ra0043 95
  • Ra0043 86
  • Ra0043 89
  • RA0043 2
  • Ra0043 15
  • Ra0043 14
  • Ra0043 12
  • Ra0043 21
  • Ra0043 22
  • Ra0043 20
  • Ra0043 60
  • Ra0043 32
  • Ra0043 31
  • Ra0043 30
  • Ra0043 33
  • Ra0043 41
  • Ra0043 43
  • Ra0043 40
  • Ra0043 42

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Certolizumab Pegol

Arm Description

Active treatment with Certolizumab Pegol; dose adjustment is based on weight.

Outcomes

Primary Outcome Measures

Certolizumab Pegol (CZP) Plasma Concentration level at Week 16
Certolizumab Pegol (CZP) Plasma Concentration level is measured in μg/mL.
Certolizumab Pegol (CZP) Plasma Concentration level at Week 48
Certolizumab Pegol (CZP) Plasma Concentration level is measured in μg/mL.
Anti-Certolizumab Pegol (anti-CZP) Antibody level at Week 16
Anti-Certolizumab Pegol (anti-CZP) Antibody level at Week 48
Incidence of serious treatment-emergent adverse events (TEAEs) during the study
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires in patient hospitalization or prolongation of existing hospitalization Is a congenital anomaly or birth defect Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of the Investigational Medicinal Product (IMP) during the study
An Adverse Event (AE) is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.

Secondary Outcome Measures

American College of Rheumatology Pediatric 30 % (PedACR30) Response at Week 16
The assessment of the PedACR30 at Week 16 compared to Baseline is based on a 30 % or greater improvement in at least 3 of the 6 core set measures with no more than 1 of the remaining worsened by >30 %. The 6 core set measures are: Number of joints with active arthritis (joints with swelling not due to deformity or inactive synovitis, or joints with limitation of motion with pain, tenderness, or both) Number of joints with limitation of range of motion Physician's Global Assessment of Disease Activity (VAS) CHAQ completed by parent or caregiver Parent's Global Assessment of Overall Well-Being (VAS) Acute phase reactant (CRP)
American College of Rheumatology Pediatric 50 % (PedACR50) Response at Week 16
The assessment of the PedACR50 at Week 16 compared to Baseline is based on a 50 % or greater improvement in at least 3 of the 6 core set measures with no more than 1 of the remaining worsened by >30 %. The 6 core set measures are: Number of joints with active arthritis (joints with swelling not due to deformity or inactive synovitis, or joints with limitation of motion with pain, tenderness, or both) Number of joints with limitation of range of motion Physician's Global Assessment of Disease Activity (VAS) CHAQ completed by parent or caregiver Parent's Global Assessment of Overall Well-Being (VAS) Acute phase reactant (CRP)
American College of Rheumatology Pediatric 70 % (PedACR70) Response at Week 16
The assessment of the PedACR70 at Week 16 compared to Baseline is based on a 70 % or greater improvement in at least 3 of the 6 core set measures with no more than 1 of the remaining worsened by >30 %. The 6 core set measures are: Number of joints with active arthritis (joints with swelling not due to deformity or inactive synovitis, or joints with limitation of motion with pain, tenderness, or both) Number of joints with limitation of range of motion Physician's Global Assessment of Disease Activity (VAS) CHAQ completed by parent or caregiver Parent's Global Assessment of Overall Well-Being (VAS) Acute phase reactant (CRP)
American College of Rheumatology Pediatric 90 % (PedACR90) Response at Week 16
The assessment of the PedACR90 at Week 16 compared to Baseline is based on a 90 % or greater improvement in at least 3 of the 6 core set measures with no more than 1 of the remaining worsened by >30 %. The 6 core set measures are: Number of joints with active arthritis (joints with swelling not due to deformity or inactive synovitis, or joints with limitation of motion with pain, tenderness, or both) Number of joints with limitation of range of motion Physician's Global Assessment of Disease Activity (VAS) CHAQ completed by parent or caregiver Parent's Global Assessment of Overall Well-Being (VAS) Acute phase reactant (CRP)

Full Information

First Posted
March 7, 2012
Last Updated
July 19, 2023
Sponsor
UCB BIOSCIENCES GmbH
Collaborators
PRA Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01550003
Brief Title
Pediatric Arthritis Study of Certolizumab Pegol
Acronym
PASCAL
Official Title
A Multicenter, Open-label Study to Assess the Pharmacokinetics, Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Polyarticular-course Juvenile Idiopathic Arthritis (JIA)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 8, 2012 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB BIOSCIENCES GmbH
Collaborators
PRA Health Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A Multicenter, Open-label Study to Assess the Pharmacokinetics, Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Polyarticular-course Juvenile Idiopathic Arthritis (JIA).
Detailed Description
The overall study consists of a Screening Period of up to 4 weeks and an Open-Label Treatment Period which will continue until the approval of the marketing application for the Polyarticular-course Juvenile Idiopathic Arthritis (JIA) indication in the study participant's country or region or until further notice from UCB (approximately 4-6 years duration; depending on region). A Final Visit will be conducted 12 weeks after last dose of study medication. Overall, study visits will occur monthly during the first 6 months and every 2 months afterwards. All patients will receive active treatment with Certolizumab Pegol. The dose will depend on actual weight. Home dosing will be allowed between study visits. If less than 50 % of the study population achieves an adequate response to the treatment (American College of Rheumatology Pediatric 30 % (PedACR30) response) at Week 16, the study will be entirely discontinued.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyarticular-course Juvenile Idiopathic Arthritis (JIA)
Keywords
Cimzia, JIA, Polyarticular, Oligoarticular, Enthesitis-related-Arthritis, Juvenile Idiopathic Arthritis, Juvenile Psoriatic Arthritis, Certolizumab Pegol, PASCAL, CDP870

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
193 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Certolizumab Pegol
Arm Type
Experimental
Arm Description
Active treatment with Certolizumab Pegol; dose adjustment is based on weight.
Intervention Type
Drug
Intervention Name(s)
Certolizumab Pegol (CZP)
Other Intervention Name(s)
Cimzia
Intervention Description
CZP will be administered subcutaneously as a fixed dose based on weight every 2 weeks (Q2W) or every 4 weeks (Q4W) throughout the study. CZP will be provided by UCB as a CZP 200 mg/ml solution for single subcutaneous (sc) injection, in a single use prefilled syringe (PFS). Each PFS contains an extractable volume of 0.25 mL, 0.5 mL or 1 mL of CZP solution. Eligible subjects will begin with 3 loading doses of CZP followed by a treatment dose for the duration of the study based on the weight range. Reduced CZP regimen (after implementation of protocol amendments 4 and 5): 10 to < 20 kg: Loading dose = 50 mg Q2W (1 x 0.25 mL sc); treatment dose = 50 mg Q4W (1 x 0.25 mL sc); 20 to < 40 kg: Loading dose = 100 mg Q2W (1 x 0.5 mL sc,); treatment dose = 50 mg Q2W (1 x 0.25 mL sc); ≥ 40 kg: Loading dose = 200 mg Q2W (1 x 1.0 mL sc); treatment dose = 100 mg Q2W (1 x 0.5 mL sc);
Intervention Type
Drug
Intervention Name(s)
Certolizumab Pegol (CZP)
Other Intervention Name(s)
Cimzia
Intervention Description
CZP will be administered subcutaneously as a fixed dose based on weight every 2 weeks (Q2W) or every 4 weeks (Q4W) throughout the study. CZP will be provided by UCB as a CZP 200 mg/ml solution for single subcutaneous (sc) injection, in a single use prefilled syringe (PFS). Each PFS contains an extractable volume of 0.25 mL, 0.5 mL or 1 mL of CZP solution. Eligible subjects will begin with 3 loading doses of CZP followed by a treatment dose for the duration of the study based on the weight range. Original CZP regimen (prior to implementation of protocol amendments 4 and 5 and after implementation of protocol amendment 9): 10 to < 20 kg: Loading dose = 100 mg Q2W (1 x 0.5 mL sc); treatment dose = 50 mg Q2W (1 x 0.25 mL sc); 20 to < 40 kg: Loading dose = 200 mg Q2W (1 x 1.0 mL sc,); treatment dose = 100 mg Q2W (1 x 0.5 mL sc); ≥ 40 kg: Loading dose = 400 mg Q2W (2 x 1.0 mL sc); treatment dose = 200 mg Q2W (1 x 1.0 mL sc);
Primary Outcome Measure Information:
Title
Certolizumab Pegol (CZP) Plasma Concentration level at Week 16
Description
Certolizumab Pegol (CZP) Plasma Concentration level is measured in μg/mL.
Time Frame
Week 16
Title
Certolizumab Pegol (CZP) Plasma Concentration level at Week 48
Description
Certolizumab Pegol (CZP) Plasma Concentration level is measured in μg/mL.
Time Frame
Week 48
Title
Anti-Certolizumab Pegol (anti-CZP) Antibody level at Week 16
Time Frame
Week 16
Title
Anti-Certolizumab Pegol (anti-CZP) Antibody level at Week 48
Time Frame
Week 48
Title
Incidence of serious treatment-emergent adverse events (TEAEs) during the study
Description
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires in patient hospitalization or prolongation of existing hospitalization Is a congenital anomaly or birth defect Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Time Frame
From Baseline (Week 0) up to the Final Visit (12 weeks after final dose of CZP)
Title
Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of the Investigational Medicinal Product (IMP) during the study
Description
An Adverse Event (AE) is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
Time Frame
From Baseline (Week 0) up to the Final Visit (12 weeks after final dose of CZP)
Secondary Outcome Measure Information:
Title
American College of Rheumatology Pediatric 30 % (PedACR30) Response at Week 16
Description
The assessment of the PedACR30 at Week 16 compared to Baseline is based on a 30 % or greater improvement in at least 3 of the 6 core set measures with no more than 1 of the remaining worsened by >30 %. The 6 core set measures are: Number of joints with active arthritis (joints with swelling not due to deformity or inactive synovitis, or joints with limitation of motion with pain, tenderness, or both) Number of joints with limitation of range of motion Physician's Global Assessment of Disease Activity (VAS) CHAQ completed by parent or caregiver Parent's Global Assessment of Overall Well-Being (VAS) Acute phase reactant (CRP)
Time Frame
Week 16
Title
American College of Rheumatology Pediatric 50 % (PedACR50) Response at Week 16
Description
The assessment of the PedACR50 at Week 16 compared to Baseline is based on a 50 % or greater improvement in at least 3 of the 6 core set measures with no more than 1 of the remaining worsened by >30 %. The 6 core set measures are: Number of joints with active arthritis (joints with swelling not due to deformity or inactive synovitis, or joints with limitation of motion with pain, tenderness, or both) Number of joints with limitation of range of motion Physician's Global Assessment of Disease Activity (VAS) CHAQ completed by parent or caregiver Parent's Global Assessment of Overall Well-Being (VAS) Acute phase reactant (CRP)
Time Frame
Week 16
Title
American College of Rheumatology Pediatric 70 % (PedACR70) Response at Week 16
Description
The assessment of the PedACR70 at Week 16 compared to Baseline is based on a 70 % or greater improvement in at least 3 of the 6 core set measures with no more than 1 of the remaining worsened by >30 %. The 6 core set measures are: Number of joints with active arthritis (joints with swelling not due to deformity or inactive synovitis, or joints with limitation of motion with pain, tenderness, or both) Number of joints with limitation of range of motion Physician's Global Assessment of Disease Activity (VAS) CHAQ completed by parent or caregiver Parent's Global Assessment of Overall Well-Being (VAS) Acute phase reactant (CRP)
Time Frame
Week 16
Title
American College of Rheumatology Pediatric 90 % (PedACR90) Response at Week 16
Description
The assessment of the PedACR90 at Week 16 compared to Baseline is based on a 90 % or greater improvement in at least 3 of the 6 core set measures with no more than 1 of the remaining worsened by >30 %. The 6 core set measures are: Number of joints with active arthritis (joints with swelling not due to deformity or inactive synovitis, or joints with limitation of motion with pain, tenderness, or both) Number of joints with limitation of range of motion Physician's Global Assessment of Disease Activity (VAS) CHAQ completed by parent or caregiver Parent's Global Assessment of Overall Well-Being (VAS) Acute phase reactant (CRP)
Time Frame
Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Study participant is 2 to 17 years of age (inclusive) at Baseline (Visit 2) Study participants must weigh ≥10 kg (22lb) at Baseline (Visit 2) Study participants must have had onset of signs and symptoms consistent with a diagnosis of Juvenile Idiopathic Arthritis (JIA) (according to the International League of Associations for Rheumatology Classification of Juvenile Idiopathic Arthritis, 2001) and initiation of JIA treatment for at least 6 months prior to Baseline (Visit 2). Eligible JIA categories include: polyarthritis rheumatoid factor-positive, polyarthritis rheumatoid factor-negative, extended oligoarthritis, juvenile psoriatic arthritis, and enthesitis-related arthritis (ERA) Study participants must have active polyarticular-course disease, defined as ≥5 joints with active arthritis at Screening and at Baseline Study participants must have had an inadequate response to, or intolerance to, at least 1 disease-modifying antirheumatic drug (DMARD) (nonbiologic or biologic). For example, study participant had prior inadequate response to methotrexate (MTX) (based on the Investigator's clinical judgment) If the study participant is using MTX, then the study participant must have been on MTX for a minimum of 3 months at Screening. In addition, the dose must have been stable for at least 1 month before Screening at ≥10 to ≤15 mg/m^2 per week. If the study participant is not using MTX, then the treatment must have been previously withdrawn for documented reasons of intolerability or inadequate response If the study participant is using oral corticosteroid therapy, the dose must have been stable for at least 7 days prior to the Baseline arthritis assessment at a maximum dose of 10 mg or 0.2 mg/kg prednisone (or equivalent) per day, whichever is the smaller dose Exclusion Criteria: Study participant has previously been exposed to more than 2 biologic agents Study participant previously failed to respond to treatment with more than one tumor necrosis factor alpha (TNFα) antagonist drug Study participant is currently receiving or has received any experimental (biological or nonbiological) therapy (within or outside a clinical study) in the 3 months or 5 half-lives prior to Baseline (Visit 2), whichever is longer Study participant had previous treatment with a biological therapy for juvenile idiopathic arthritis (JIA) that resulted in a severe hypersensitivity reaction or an anaphylactic reaction Study participant previously participated in this study or has previously been treated with CZP (whether in a study or not) Study participant has a history of systemic JIA, with or without systemic features Study participant has a secondary, noninflammatory type of rheumatic disease or of joint pains (eg, fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of study medication Study participant has other inflammatory arthritis (eg, systemic lupus erythematosus, inflammatory bowel disease-related) Study participant has active uveitis or a history of active uveitis within the preceding 6 months Study participant has current, chronic or recurrent clinically significant infections Study participant has a current sign or symptom which may indicate infection (eg, fever, cough), a history of chronic or recurrent infections within the same organ system (more than 3 episodes requiring antibiotics/antivirals during the 12 months prior to Screening [Visit 1]), had a recent (within the 6 months prior to Screening [Visit 1]) serious or life-threatening infection (including herpes zoster), or is at a high risk of infection in the Investigator's opinion (eg, study participants with leg ulcers, indwelling urinary catheter, and persistent or recurrent chest infections or permanently bed-ridden or wheelchair bound)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Ra0043 71
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Ra0043 79
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027-6062
Country
United States
Facility Name
Ra0043 84
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Ra0043 83
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Ra0043 81
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Ra0043 82
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Ra0043 90
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Ra0043 75
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Ra0043 80
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Ra0043 77
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Ra0043 85
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Ra0043 87
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Ra0043 74
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Ra0043 76
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Ra0043 70
City
Avon
State/Province
Ohio
ZIP/Postal Code
44011
Country
United States
Facility Name
Ra0043 73
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Ra0043 78
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Ra0043 95
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ra0043 86
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205-2694
Country
United States
Facility Name
Ra0043 89
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
RA0043 2
City
Buenos Aires
Country
Argentina
Facility Name
Ra0043 15
City
Curitiba
Country
Brazil
Facility Name
Ra0043 14
City
Porto Alegre
Country
Brazil
Facility Name
Ra0043 12
City
Sao Paulo
Country
Brazil
Facility Name
Ra0043 21
City
Calgary
Country
Canada
Facility Name
Ra0043 22
City
Montreal
Country
Canada
Facility Name
Ra0043 20
City
Toronto
Country
Canada
Facility Name
Ra0043 60
City
Santiago
Country
Chile
Facility Name
Ra0043 32
City
Mexico D.F.
Country
Mexico
Facility Name
Ra0043 31
City
Mexico
Country
Mexico
Facility Name
Ra0043 30
City
Monterrey
Country
Mexico
Facility Name
Ra0043 33
City
San Luis Potosi
Country
Mexico
Facility Name
Ra0043 41
City
Moscow
Country
Russian Federation
Facility Name
Ra0043 43
City
Moscow
Country
Russian Federation
Facility Name
Ra0043 40
City
St. Petersburg
Country
Russian Federation
Facility Name
Ra0043 42
City
Tolyatti
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
IPD Sharing Time Frame
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
IPD Sharing Access Criteria
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
IPD Sharing URL
https://vivli.org

Learn more about this trial

Pediatric Arthritis Study of Certolizumab Pegol

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