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A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis

Primary Purpose

Moderate to Severe Psoriasis, Generalized Pustular Psoriasis and Erythrodermic Psoriasis

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Placebo
Certolizumab Pegol
Sponsored by
UCB Biopharma S.P.R.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate to Severe Psoriasis focused on measuring Psoriasis, PSO, Chronic plaque psoriasis, Certolizumb Pegol, Cimzia, Generalized pustular psoriasis and erythrodermic psoriasis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject is male or female, >= 20 years of age.
  • Institutional Review Board-approved written informed consent form is signed and dated by the subject.
  • Other protocol-defined inclusion criteria may apply.

For subjects with moderate to severe chronic plaque psoriasis (PSO)

  • Chronic plaque psoriasis for at least 6 months.
  • Baseline Psoriasis Activity and Severity Index (PASI) >=12 and Body Surface Area (BSA) affected by PSO >=10% and Physician's Global Assessment (PGA) score of 3 or higher.
  • Candidates for systemic PSO therapy and/or phototherapy and/or chemophototherapy.

For subjects with generalized pustular PSO or erythrodermic PSO

  • Diagnosis of generalized pustular PSO or erythrodermic PSO at Screening.
  • History of plaque-type PSO if subjects have a diagnosis of erythrodermic PSO.
  • Baseline BSA affected by PSO >=80% if subjects have a diagnosis of erythrodermic PSO.

Exclusion Criteria:

  • Female subject who is breastfeeding, pregnant, or plans to become pregnant during the study or within 5 months following last dose of study drug. Male subject who is planning a partner pregnancy during the study or within 5 months following the last dose of study drug.
  • Subject has guttate psoriasis or drug-induced psoriasis. For subjects with moderate to severe plaque psoriasis, erythrodermic or pustular forms of psoriasis also are excluded.
  • History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol. Also, subjects with a high risk of infection in the Investigator's opinion.
  • History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease.
  • History of other malignancy or concurrent malignancy as described in the protocol.
  • Class III or IV congestive heart failure
  • History of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis).
  • Subject has any other condition which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study.
  • Concurrent medication restrictions as described in the protocol.
  • Subject with known tuberculosis (TB) infection, at high risk of acquiring TB infection, or with untreated latent tuberculosis infection (LTBI) or current or history of nontuberculous mycobacterial (NTMB) infection.
  • Subject has any protocol defined clinically significant laboratory abnormalities at the screening
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

  • Ps0017 024
  • Ps0017 012
  • Ps0017 010
  • Ps0017 007
  • Ps0017 004
  • Ps0017 039
  • Ps0017 028
  • Ps0017 040
  • Ps0017 013
  • Ps0017 022
  • Ps0017 032
  • Ps0017 031
  • Ps0017 021
  • Ps0017 041
  • Ps0017 009
  • Ps0017 033
  • Ps0017 016
  • Ps0017 029
  • Ps0017 005
  • Ps0017 037
  • Ps0017 017
  • Ps0017 042
  • Ps0017 001
  • Ps0017 027
  • Ps0017 015
  • Ps0017 008
  • Ps0017 002
  • Ps0017 003
  • Ps0017 011
  • Ps0017 014
  • Ps0017 034
  • Ps0017 038
  • Ps0017 025

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

CZP 200 mg

CZP 400 mg

Arm Description

Placebo subcutaneous (sc) injection every two weeks (Q2W)

Certolizumab Pegol subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) with PBO administered to maintain the blind, starting at Week 6

Certolizumab Pegol subcutaneous (sc) injection 400 mg every two weeks (Q2W).

Outcomes

Primary Outcome Measures

Percentage of Subjects Achieving a 75 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16
The PASI75 response assessments were based on at least 75 % improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Secondary Outcome Measures

Percentage of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2-category Improvement) at Week 16
This Outcome Measure applied to participants with moderate to severe chronic plaque Psoriasis (PSO). The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.
Percentage of Subjects Achieving a 90 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16
The PASI90 response assessments were based on at least 90 % improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
This Outcome Measure applied to participants with moderate to severe chronic plaque Psoriasis (PSO). The DLQI is a subject-reported questionnaire designed for use in adult participants with PSO. The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect patients' health related quality of life (HRQoL). This instrument asked participants about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has been shown to be valid and reproducible in PSO patients. The DLQI score ranges from 0 to 30 with higher scores indicating lower HRQoL. A higher than or equal to (>=) 4-point change in the DLQI score (DLQI response) has been reported to be meaningful for the patient (within-patient minimal important difference Basra et al, 2015) a DLQI absolute score of lower than or equal to (=<) 1 indicates DLQI remission (i.e., no or small impact of the disease on HRQoL).
Change From Baseline in Itch Numeric Rating Scale at Week 16
This Outcome Measure applied to participants with moderate to severe chronic plaque Psoriasis (PSO). The Itch Numeric Rating Scale (NRS) has been developed as a simple, single item instrument to assess the patient-reported severity of itch at its most intense during the past 24h period. Participants indicate itch severity by circling the integer that best describes the worst level of itching due to PSO in the past 24h period on an 11-point scale anchored at 0, representing "no itching" and 10, representing "worst itch imaginable" (Kimball et al, 2016).
Plasma Concentration of Certolizumab Pegol (CZP)
Plasma concentration was expressed in micrograms per milliliter (μg/mL). Values below Lower Limit of Quantification (LLOQ) were set to half the LLOQ to present summaries. The geometric mean and geometric coefficient of variation were only displayed if at least 2/3 of the data were above the LLOQ.
Percentage of Participants With Positive Anti-Certolizumab Pegol-antibody Levels in Plasma
A pre-anti-drug (CZP) antibody (ADA) positive subject was defined as having a confirmed positive sample at Baseline. A pre-ADA negative subject was defined as having a Screening below the cut point (BCP) sample, or a screening above the cut point (ACP) sample, but not confirmed positive at Baseline. A treatment-emergent ADA positive subject was defined as either 1) pre-ADA negative subjects having at least 1 ADA confirmed positive sample or 2) pre-ADA positive subjects with at least 1 sample with greater then or equal to (>=) 1.67-fold increase from Baseline on CZP treatment.

Full Information

First Posted
February 9, 2017
Last Updated
December 13, 2021
Sponsor
UCB Biopharma S.P.R.L.
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1. Study Identification

Unique Protocol Identification Number
NCT03051217
Brief Title
A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis
Official Title
Phase 2/3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 21, 2017 (Actual)
Primary Completion Date
November 19, 2018 (Actual)
Study Completion Date
January 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma S.P.R.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to demonstrate the efficacy and safety of Certolizumab Pegol (CZP) in the treatment of moderate to severe chronic plaque Psoriasis (PSO) in Japanese subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Psoriasis, Generalized Pustular Psoriasis and Erythrodermic Psoriasis
Keywords
Psoriasis, PSO, Chronic plaque psoriasis, Certolizumb Pegol, Cimzia, Generalized pustular psoriasis and erythrodermic psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo subcutaneous (sc) injection every two weeks (Q2W)
Arm Title
CZP 200 mg
Arm Type
Experimental
Arm Description
Certolizumab Pegol subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) with PBO administered to maintain the blind, starting at Week 6
Arm Title
CZP 400 mg
Arm Type
Experimental
Arm Description
Certolizumab Pegol subcutaneous (sc) injection 400 mg every two weeks (Q2W).
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
PBO
Intervention Description
Pharmaceutical Form: Solution for injection in pre-filled syringe Concentration: 0.9 % saline Route of Administration: Subcutaneous use Q2W
Intervention Type
Drug
Intervention Name(s)
Certolizumab Pegol
Other Intervention Name(s)
Cimzia, CDP870, CZP
Intervention Description
Pharmaceutical Form: Solution for injection in pre-filled syringe Concentration: 200 mg/mL Route of Administration: Subcutaneous use
Primary Outcome Measure Information:
Title
Percentage of Subjects Achieving a 75 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16
Description
The PASI75 response assessments were based on at least 75 % improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2-category Improvement) at Week 16
Description
This Outcome Measure applied to participants with moderate to severe chronic plaque Psoriasis (PSO). The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.
Time Frame
Week 16
Title
Percentage of Subjects Achieving a 90 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16
Description
The PASI90 response assessments were based on at least 90 % improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Time Frame
Week 16
Title
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
Description
This Outcome Measure applied to participants with moderate to severe chronic plaque Psoriasis (PSO). The DLQI is a subject-reported questionnaire designed for use in adult participants with PSO. The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect patients' health related quality of life (HRQoL). This instrument asked participants about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has been shown to be valid and reproducible in PSO patients. The DLQI score ranges from 0 to 30 with higher scores indicating lower HRQoL. A higher than or equal to (>=) 4-point change in the DLQI score (DLQI response) has been reported to be meaningful for the patient (within-patient minimal important difference Basra et al, 2015) a DLQI absolute score of lower than or equal to (=<) 1 indicates DLQI remission (i.e., no or small impact of the disease on HRQoL).
Time Frame
Baseline and Week 16
Title
Change From Baseline in Itch Numeric Rating Scale at Week 16
Description
This Outcome Measure applied to participants with moderate to severe chronic plaque Psoriasis (PSO). The Itch Numeric Rating Scale (NRS) has been developed as a simple, single item instrument to assess the patient-reported severity of itch at its most intense during the past 24h period. Participants indicate itch severity by circling the integer that best describes the worst level of itching due to PSO in the past 24h period on an 11-point scale anchored at 0, representing "no itching" and 10, representing "worst itch imaginable" (Kimball et al, 2016).
Time Frame
Baseline and Week 16
Title
Plasma Concentration of Certolizumab Pegol (CZP)
Description
Plasma concentration was expressed in micrograms per milliliter (μg/mL). Values below Lower Limit of Quantification (LLOQ) were set to half the LLOQ to present summaries. The geometric mean and geometric coefficient of variation were only displayed if at least 2/3 of the data were above the LLOQ.
Time Frame
Blood samples were collected at Baseline (Week 0) and at Weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, 52, 60
Title
Percentage of Participants With Positive Anti-Certolizumab Pegol-antibody Levels in Plasma
Description
A pre-anti-drug (CZP) antibody (ADA) positive subject was defined as having a confirmed positive sample at Baseline. A pre-ADA negative subject was defined as having a Screening below the cut point (BCP) sample, or a screening above the cut point (ACP) sample, but not confirmed positive at Baseline. A treatment-emergent ADA positive subject was defined as either 1) pre-ADA negative subjects having at least 1 ADA confirmed positive sample or 2) pre-ADA positive subjects with at least 1 sample with greater then or equal to (>=) 1.67-fold increase from Baseline on CZP treatment.
Time Frame
Blood samples will be collected at Baseline (Week 0) and at Weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, 52, 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is male or female, >= 20 years of age. Institutional Review Board-approved written informed consent form is signed and dated by the subject. Other protocol-defined inclusion criteria may apply. For subjects with moderate to severe chronic plaque psoriasis (PSO) Chronic plaque psoriasis for at least 6 months. Baseline Psoriasis Activity and Severity Index (PASI) >=12 and Body Surface Area (BSA) affected by PSO >=10% and Physician's Global Assessment (PGA) score of 3 or higher. Candidates for systemic PSO therapy and/or phototherapy and/or chemophototherapy. For subjects with generalized pustular PSO or erythrodermic PSO Diagnosis of generalized pustular PSO or erythrodermic PSO at Screening. History of plaque-type PSO if subjects have a diagnosis of erythrodermic PSO. Baseline BSA affected by PSO >=80% if subjects have a diagnosis of erythrodermic PSO. Exclusion Criteria: Female subject who is breastfeeding, pregnant, or plans to become pregnant during the study or within 5 months following last dose of study drug. Male subject who is planning a partner pregnancy during the study or within 5 months following the last dose of study drug. Subject has guttate psoriasis or drug-induced psoriasis. For subjects with moderate to severe plaque psoriasis, erythrodermic or pustular forms of psoriasis also are excluded. History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol. Also, subjects with a high risk of infection in the Investigator's opinion. History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease. History of other malignancy or concurrent malignancy as described in the protocol. Class III or IV congestive heart failure History of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis). Subject has any other condition which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study. Concurrent medication restrictions as described in the protocol. Subject with known tuberculosis (TB) infection, at high risk of acquiring TB infection, or with untreated latent tuberculosis infection (LTBI) or current or history of nontuberculous mycobacterial (NTMB) infection. Subject has any protocol defined clinically significant laboratory abnormalities at the screening Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
UCB (+1 844 599 2273)
Official's Role
Study Director
Facility Information:
Facility Name
Ps0017 024
City
Asahikawa
Country
Japan
Facility Name
Ps0017 012
City
Bunkyo-Ku
Country
Japan
Facility Name
Ps0017 010
City
Chiyoda-Ku
Country
Japan
Facility Name
Ps0017 007
City
Chūōku
Country
Japan
Facility Name
Ps0017 004
City
Fukuoka
Country
Japan
Facility Name
Ps0017 039
City
Fukushima
Country
Japan
Facility Name
Ps0017 028
City
Gifu
Country
Japan
Facility Name
Ps0017 040
City
Hamamatsu
Country
Japan
Facility Name
Ps0017 013
City
Itabashi-Ku
Country
Japan
Facility Name
Ps0017 022
City
Kobe
Country
Japan
Facility Name
Ps0017 032
City
Kumamoto
Country
Japan
Facility Name
Ps0017 031
City
Kurume
Country
Japan
Facility Name
Ps0017 021
City
Kyoto
Country
Japan
Facility Name
Ps0017 041
City
Matsumoto
Country
Japan
Facility Name
Ps0017 009
City
Minatoku
Country
Japan
Facility Name
Ps0017 033
City
Miyazaki
Country
Japan
Facility Name
Ps0017 016
City
Nagoya
Country
Japan
Facility Name
Ps0017 029
City
Nankoku
Country
Japan
Facility Name
Ps0017 005
City
Obihiro
Country
Japan
Facility Name
Ps0017 037
City
Osaka-Sayama
Country
Japan
Facility Name
Ps0017 017
City
Osaka
Country
Japan
Facility Name
Ps0017 042
City
Osaka
Country
Japan
Facility Name
Ps0017 001
City
Sapporo
Country
Japan
Facility Name
Ps0017 027
City
Sendai
Country
Japan
Facility Name
Ps0017 015
City
Shimotsuke
Country
Japan
Facility Name
Ps0017 008
City
Shinagawa-Ku
Country
Japan
Facility Name
Ps0017 002
City
Shinjuku
Country
Japan
Facility Name
Ps0017 003
City
Shinjuku
Country
Japan
Facility Name
Ps0017 011
City
Shinjuku
Country
Japan
Facility Name
Ps0017 014
City
Shinjuku
Country
Japan
Facility Name
Ps0017 034
City
Sumida
Country
Japan
Facility Name
Ps0017 038
City
Takaoka
Country
Japan
Facility Name
Ps0017 025
City
Tsu
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
34826124
Citation
Imafuku S, Tada Y, Umezawa Y, Sakurai S, Hoshii N, Nakagawa H. Certolizumab Pegol in Japanese Patients with Moderate to Severe Plaque Psoriasis: Effect of Demographics and Baseline Disease Characteristics on Efficacy. Dermatol Ther (Heidelb). 2022 Jan;12(1):121-135. doi: 10.1007/s13555-021-00645-2. Epub 2021 Nov 26.
Results Reference
result
PubMed Identifier
35622315
Citation
Okubo Y, Umezawa Y, Sakurai S, Hoshii N, Nakagawa H. Efficacy and Safety of Certolizumab Pegol in Japanese Patients with Generalized Pustular Psoriasis and Erythrodermic Psoriasis: 52-Week Results. Dermatol Ther (Heidelb). 2022 Jun;12(6):1397-1415. doi: 10.1007/s13555-022-00741-x. Epub 2022 May 27.
Results Reference
derived
PubMed Identifier
33886085
Citation
Umezawa Y, Asahina A, Imafuku S, Tada Y, Sano S, Morita A, Sakurai S, Hoshii N, Tilt N, Nakagawa H. Efficacy and Safety of Certolizumab Pegol in Japanese Patients with Moderate to Severe Plaque Psoriasis: 52-Week Results. Dermatol Ther (Heidelb). 2021 Jun;11(3):943-960. doi: 10.1007/s13555-021-00520-0. Epub 2021 Apr 22.
Results Reference
derived
PubMed Identifier
33606269
Citation
Umezawa Y, Sakurai S, Hoshii N, Nakagawa H; PS0017 Study Group. Certolizumab Pegol for the Treatment of Moderate to Severe Plaque Psoriasis: 16-Week Results from a Phase 2/3 Japanese Study. Dermatol Ther (Heidelb). 2021 Apr;11(2):513-528. doi: 10.1007/s13555-021-00494-z. Epub 2021 Feb 19.
Results Reference
derived
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis

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