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Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Certolizumab Pegol (CZP)
Adalimumab (ADA)
Methotrexate (MTX)
Sponsored by
UCB Pharma SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Certolizumab Pegol, Cimzia, Adalimumab, Humira, Rheumatoid Arthritis

Eligibility Criteria

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

Inclusion Criteria:

  • Subject must have a diagnosis of Rheumatoid Arthritis (RA) at Screening, as defined by the 2010 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria (Aletaha D et al, 2010)
  • Subject must have a positive Rheumatoid Factor (RF) and/or a positive anti-Cyclic Citrullinated Peptide antibody (anti-CCP) as determined by the central laboratory at Screening

  • Subject must have moderate to severe RA disease at Screening and Baseline defined as:

    1. Screening (all criteria required)

      • ≥ 4 swollen joints (of 28 prespecified joints)
      • Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) > 3.2
      • C-Reactive Protein (CRP) concentration ≥ 10 mg/L (or 1.0 mg/dL) or Erythrocyte Sedimentation Rate (ESR) (Westergren) ≥ 28 mm/hr

    2. Baseline (both criteria required)

      • ≥ 4 swollen joints (of 28 prespecified joints)
      • Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) > 3.2
  • Subject must have inadequately responded previously to Methotrexate (MTX)
  • Subject is using MTX 15 to 25 mg/week orally or subcutaneously at Screening and has used the same MTX regimen for a minimum of 28 days prior to Baseline

Exclusion Criteria:

  • Subject has previously received any biological Disease Modifying Antirheumatic Drug (DMARD) or has received treatment with cyclophosphamide, chlorambucil, Janus Kinase, phosphodiesterase 4 inhibitors or investigational agents such as spleen tyrosine kinase
  • Diagnosis of any other inflammatory arthritis
  • Infected with Tuberculosis (TB) or high risk of acquiring TB infection
  • Subjects with concurrent acute or chronic viral hepatitis B or C infection
  • Subjects with a history of chronic or recurrent infections or subjects at high risk of infection
  • Use of prohibited medications like nonbiological DMARDs (excluding MTX), biological DMARDs excluding study medications, experimental therapy, IA hyaluronic acid

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Certolizumab Pegol + Methotrexate (CZP + MTX)

Adalimumab + Methotrexate (ADA + MTX)

CZP + MTX followed by ADA + MTX

ADA + MTX followed by CZP + MTX

Arm Description

Those subjects who received Certolizumab Pegol (400 mg at Weeks 0, 2, 4 followed by 200 mg every two weeks) + Methotrexate (CZP+ MTX) at Baseline and are Non-Responders at Week 12, switch to Adalimumab (40 mg) + Methotrexate (ADA + MTX) after Week 12.

Those subjects who received Adalimumab (40 mg + Placebo at Weeks 0, 2, 4 followed by 40 mg ADA every two weeks) + Methotrexate (ADA+ MTX) at Baseline and are Non-Responders at Week 12, switch to Certolizumab Pegol (400 mg at Weeks 12, 14, 16 followed by 200 mg every two weeks) + Methotrexate (CZP+ MTX) after Week 12.

Outcomes

Primary Outcome Measures

Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 12
Subjects who met the ACR20 criteria were those subjects with at least 20% improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).
Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104
DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.

Secondary Outcome Measures

Percentage of Week 12 Responders Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104
DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity. The definition of Week 12 responders was DAS28[ESR] Low Disease Activity (LDA) (ie ≤ 3.2) or an improvement of ≥ 1.2 in DAS28[ESR] relative to Baseline.
Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 6
Subjects who met the ACR20 criteria were those subjects with at least 20% improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).
Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 6
DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.
Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 12
DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.
Percentage of Subjects With a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104, in Subjects Responding at Both Week 6 and Week 12
DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity. The definition of Week 6/12 responders was DAS28[ESR] Low Disease Activity (LDA) (ie ≤ 3.2) or an improvement of ≥ 1.2 in DAS28[ESR] relative to Baseline.
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 104
HAQ-DI was derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question was scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), and the total HAQ-DI was scored on the scale of 0-3 as well. Change from Baseline was computed as the value at Week 104 minus the Baseline value. A negative value in Change from Baseline indicates an improvement.
Kaplan-Meier Estimates of Proportion of Subjects Who Discontinued After Response at Week 12
Response at Week 12 means that a subject had either a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 12 or had a reduction of DAS28 [ESR] ≥ 1.2 from Baseline to Week 12. Kaplan-Meier Estimates of Proportion of Subjects Discontinued are presented per study week (days relative to Week 12 visit).

Full Information

First Posted
December 22, 2011
Last Updated
July 4, 2018
Sponsor
UCB Pharma SA
Collaborators
Parexel
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1. Study Identification

Unique Protocol Identification Number
NCT01500278
Brief Title
Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate
Official Title
A Multicenter, Single-blind, Randomized Parallel-group Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis Responding Inadequately to Methotrexate
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma SA
Collaborators
Parexel

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is conducted to evaluate the short (12 Weeks) and long term (104 Weeks) efficacy of Certolizumab Pegol compared with Adalimumab both in combination with Methotrexate (MTX) in the treatment of moderate to severe Rheumatoid Arthritis (RA) that is not responding adequately to MTX.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Certolizumab Pegol, Cimzia, Adalimumab, Humira, Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
915 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Certolizumab Pegol + Methotrexate (CZP + MTX)
Arm Type
Active Comparator
Arm Title
Adalimumab + Methotrexate (ADA + MTX)
Arm Type
Active Comparator
Arm Title
CZP + MTX followed by ADA + MTX
Arm Type
Active Comparator
Arm Description
Those subjects who received Certolizumab Pegol (400 mg at Weeks 0, 2, 4 followed by 200 mg every two weeks) + Methotrexate (CZP+ MTX) at Baseline and are Non-Responders at Week 12, switch to Adalimumab (40 mg) + Methotrexate (ADA + MTX) after Week 12.
Arm Title
ADA + MTX followed by CZP + MTX
Arm Type
Active Comparator
Arm Description
Those subjects who received Adalimumab (40 mg + Placebo at Weeks 0, 2, 4 followed by 40 mg ADA every two weeks) + Methotrexate (ADA+ MTX) at Baseline and are Non-Responders at Week 12, switch to Certolizumab Pegol (400 mg at Weeks 12, 14, 16 followed by 200 mg every two weeks) + Methotrexate (CZP+ MTX) after Week 12.
Intervention Type
Biological
Intervention Name(s)
Certolizumab Pegol (CZP)
Other Intervention Name(s)
Cimzia, CZP
Intervention Description
Active substance: an injectable volume of 1 ml solution for injection CZP Pharmaceutical form: prefilled syringes CZP Concentration: 200 mg/ml CZP Route of Administration: injections will be given subcutaneously: loading dose of CZP 400 mg at Baseline, and Weeks 2 and 4, followed by a maintenance dose of 200 mg every 2 weeks through Week 102 or withdrawal.
Intervention Type
Biological
Intervention Name(s)
Adalimumab (ADA)
Other Intervention Name(s)
Humira, ADA
Intervention Description
Active substance: an injectable volume of 0.8 ml solution for injection ADA Pharmaceutical form: prefilled syringes ADA Concentration: 40 mg/0.8 ml ADA Route of Administration: injections will be given subcutaneously. ADA 40 mg plus an injection with Placebo (to preserve blind) at Baseline, and Weeks 2 and 4, followed by ADA 40 mg every 2 weeks through Week 102 or withdrawal.
Intervention Type
Drug
Intervention Name(s)
Methotrexate (MTX)
Other Intervention Name(s)
MTX
Intervention Description
Active substance: Methotrexate Pharmaceutical form: oral tablet Concentration: 15-25 mg/week Route of Administration: MTX orally
Primary Outcome Measure Information:
Title
Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 12
Description
Subjects who met the ACR20 criteria were those subjects with at least 20% improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).
Time Frame
Week 12
Title
Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104
Description
DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.
Time Frame
Week 104
Secondary Outcome Measure Information:
Title
Percentage of Week 12 Responders Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104
Description
DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity. The definition of Week 12 responders was DAS28[ESR] Low Disease Activity (LDA) (ie ≤ 3.2) or an improvement of ≥ 1.2 in DAS28[ESR] relative to Baseline.
Time Frame
Week 104
Title
Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 6
Description
Subjects who met the ACR20 criteria were those subjects with at least 20% improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).
Time Frame
Week 6
Title
Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 6
Description
DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.
Time Frame
Week 6
Title
Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 12
Description
DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.
Time Frame
Week 12
Title
Percentage of Subjects With a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104, in Subjects Responding at Both Week 6 and Week 12
Description
DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity. The definition of Week 6/12 responders was DAS28[ESR] Low Disease Activity (LDA) (ie ≤ 3.2) or an improvement of ≥ 1.2 in DAS28[ESR] relative to Baseline.
Time Frame
Week 104
Title
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 104
Description
HAQ-DI was derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question was scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), and the total HAQ-DI was scored on the scale of 0-3 as well. Change from Baseline was computed as the value at Week 104 minus the Baseline value. A negative value in Change from Baseline indicates an improvement.
Time Frame
From Baseline to Week 104
Title
Kaplan-Meier Estimates of Proportion of Subjects Who Discontinued After Response at Week 12
Description
Response at Week 12 means that a subject had either a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 12 or had a reduction of DAS28 [ESR] ≥ 1.2 from Baseline to Week 12. Kaplan-Meier Estimates of Proportion of Subjects Discontinued are presented per study week (days relative to Week 12 visit).
Time Frame
From Week 12 up to Week 104

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject must have a diagnosis of Rheumatoid Arthritis (RA) at Screening, as defined by the 2010 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria (Aletaha D et al, 2010) Subject must have a positive Rheumatoid Factor (RF) and/or a positive anti-Cyclic Citrullinated Peptide antibody (anti-CCP) as determined by the central laboratory at Screening Subject must have moderate to severe RA disease at Screening and Baseline defined as: Screening (all criteria required) ≥ 4 swollen joints (of 28 prespecified joints) Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) > 3.2 C-Reactive Protein (CRP) concentration ≥ 10 mg/L (or 1.0 mg/dL) or Erythrocyte Sedimentation Rate (ESR) (Westergren) ≥ 28 mm/hr Baseline (both criteria required) ≥ 4 swollen joints (of 28 prespecified joints) Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) > 3.2 Subject must have inadequately responded previously to Methotrexate (MTX) Subject is using MTX 15 to 25 mg/week orally or subcutaneously at Screening and has used the same MTX regimen for a minimum of 28 days prior to Baseline Exclusion Criteria: Subject has previously received any biological Disease Modifying Antirheumatic Drug (DMARD) or has received treatment with cyclophosphamide, chlorambucil, Janus Kinase, phosphodiesterase 4 inhibitors or investigational agents such as spleen tyrosine kinase Diagnosis of any other inflammatory arthritis Infected with Tuberculosis (TB) or high risk of acquiring TB infection Subjects with concurrent acute or chronic viral hepatitis B or C infection Subjects with a history of chronic or recurrent infections or subjects at high risk of infection Use of prohibited medications like nonbiological DMARDs (excluding MTX), biological DMARDs excluding study medications, experimental therapy, IA hyaluronic acid
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
141
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
214
City
Tuscaloosa
State/Province
Alabama
Country
United States
Facility Name
159
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
152
City
Hot Springs
State/Province
Arkansas
Country
United States
Facility Name
147
City
Covina
State/Province
California
Country
United States
Facility Name
161
City
Fullerton
State/Province
California
Country
United States
Facility Name
217
City
La Mesa
State/Province
California
Country
United States
Facility Name
149
City
Los Angeles
State/Province
California
Country
United States
Facility Name
144
City
Menifee
State/Province
California
Country
United States
Facility Name
185
City
Roseville
State/Province
California
Country
United States
Facility Name
208
City
Sacramento
State/Province
California
Country
United States
Facility Name
189
City
Van Nuys
State/Province
California
Country
United States
Facility Name
148
City
Whittier
State/Province
California
Country
United States
Facility Name
220
City
Lewes
State/Province
Delaware
Country
United States
Facility Name
142
City
Aventura
State/Province
Florida
Country
United States
Facility Name
216
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
162
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
209
City
Vero Beach
State/Province
Florida
Country
United States
Facility Name
145
City
Coeur d'Alene
State/Province
Idaho
Country
United States
Facility Name
202
City
Maywood
State/Province
Illinois
Country
United States
Facility Name
134
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
178
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
137
City
Battle Creek
State/Province
Michigan
Country
United States
Facility Name
153
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
155
City
Lansing
State/Province
Michigan
Country
United States
Facility Name
204
City
Eagan
State/Province
Minnesota
Country
United States
Facility Name
180
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
143
City
Saint Louis Park
State/Province
Minnesota
Country
United States
Facility Name
135
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
170
City
Reno
State/Province
Nevada
Country
United States
Facility Name
201
City
Teaneck
State/Province
New Jersey
Country
United States
Facility Name
150
City
Voorhees
State/Province
New Jersey
Country
United States
Facility Name
205
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
154
City
Albany
State/Province
New York
Country
United States
Facility Name
136
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
219
City
Orchard Park
State/Province
New York
Country
United States
Facility Name
207
City
Plainview
State/Province
New York
Country
United States
Facility Name
167
City
Syracuse
State/Province
New York
Country
United States
Facility Name
140
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
184
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
164
City
Bethlehem
State/Province
Pennsylvania
Country
United States
Facility Name
132
City
Duncansville
State/Province
Pennsylvania
Country
United States
Facility Name
190
City
Wyomissing
State/Province
Pennsylvania
Country
United States
Facility Name
210
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
187
City
Myrtle Beach
State/Province
South Carolina
Country
United States
Facility Name
203
City
Orangeburg
State/Province
South Carolina
Country
United States
Facility Name
133
City
Jackson
State/Province
Tennessee
Country
United States
Facility Name
160
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
138
City
Austin
State/Province
Texas
Country
United States
Facility Name
151
City
Corpus Christi
State/Province
Texas
Country
United States
Facility Name
131
City
Dallas
State/Province
Texas
Country
United States
Facility Name
146
City
Dallas
State/Province
Texas
Country
United States
Facility Name
213
City
Dallas
State/Province
Texas
Country
United States
Facility Name
166
City
Houston
State/Province
Texas
Country
United States
Facility Name
212
City
Houston
State/Province
Texas
Country
United States
Facility Name
139
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
181
City
Sugar Land
State/Province
Texas
Country
United States
Facility Name
165
City
Victoria
State/Province
Texas
Country
United States
Facility Name
211
City
Arlington
State/Province
Virginia
Country
United States
Facility Name
157
City
Spokane
State/Province
Washington
Country
United States
Facility Name
163
City
Clarksburg
State/Province
West Virginia
Country
United States
Facility Name
215
City
Glendale
State/Province
Wisconsin
Country
United States
Facility Name
6
City
Camperdown
State/Province
New South Wales
Country
Australia
Facility Name
5
City
Kogarah
State/Province
New South Wales
Country
Australia
Facility Name
2
City
Maroochydore
State/Province
Queensland
Country
Australia
Facility Name
4
City
Hobart
State/Province
Tasmania
Country
Australia
Facility Name
7
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
8
City
Fitzroy
State/Province
Victoria
Country
Australia
Facility Name
1
City
Malvern
State/Province
Victoria
Country
Australia
Facility Name
3
City
Subiaco
State/Province
Western Australia
Country
Australia
Facility Name
85
City
Stockerau
Country
Austria
Facility Name
22
City
Wien
Country
Austria
Facility Name
18
City
Pleven
Country
Bulgaria
Facility Name
35
City
Plovdiv
Country
Bulgaria
Facility Name
21
City
Sofia
Country
Bulgaria
Facility Name
29
City
Sofia
Country
Bulgaria
Facility Name
34
City
Sofia
Country
Bulgaria
Facility Name
46
City
Sofia
Country
Bulgaria
Facility Name
179
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
168
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
176
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
183
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
172
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
174
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
177
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
206
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
175
City
St. Catharines
State/Province
Ontario
Country
Canada
Facility Name
218
City
Rimouski
State/Province
Quebec
Country
Canada
Facility Name
169
City
Sainte Foy
State/Province
Quebec
Country
Canada
Facility Name
221
City
Barrie
Country
Canada
Facility Name
171
City
Quebec
Country
Canada
Facility Name
103
City
Brno
Country
Czechia
Facility Name
61
City
Hradec Kralove
Country
Czechia
Facility Name
58
City
Plzen
Country
Czechia
Facility Name
49
City
Praha
Country
Czechia
Facility Name
40
City
Uherske Hradiste
Country
Czechia
Facility Name
89
City
Brest
Country
France
Facility Name
70
City
Le Mans
Country
France
Facility Name
62
City
Lyon
Country
France
Facility Name
72
City
Montpellier Cedex 5
Country
France
Facility Name
90
City
Orleans
Country
France
Facility Name
105
City
Toulouse Cedex 9
Country
France
Facility Name
56
City
Berlin
Country
Germany
Facility Name
47
City
Fulda
Country
Germany
Facility Name
17
City
Hamburg
Country
Germany
Facility Name
31
City
Heidelberg
Country
Germany
Facility Name
37
City
Herne
Country
Germany
Facility Name
64
City
Köln
Country
Germany
Facility Name
63
City
Osnabrück
Country
Germany
Facility Name
11
City
Ratingen
Country
Germany
Facility Name
66
City
Rheine
Country
Germany
Facility Name
48
City
Rostock
Country
Germany
Facility Name
71
City
Traunstein
Country
Germany
Facility Name
44
City
Zerbst
Country
Germany
Facility Name
94
City
Heraklion
Country
Greece
Facility Name
95
City
Larisa
Country
Greece
Facility Name
13
City
Budapest
Country
Hungary
Facility Name
42
City
Budapest
Country
Hungary
Facility Name
68
City
Gyula
Country
Hungary
Facility Name
100
City
Kistarcsa
Country
Hungary
Facility Name
43
City
Szeged
Country
Hungary
Facility Name
33
City
Veszprem
Country
Hungary
Facility Name
23
City
Dublin
Country
Ireland
Facility Name
51
City
Dublin
Country
Ireland
Facility Name
20
City
Limerick
Country
Ireland
Facility Name
80
City
Bergamo
Country
Italy
Facility Name
38
City
Genova
Country
Italy
Facility Name
88
City
Genova
Country
Italy
Facility Name
79
City
Magenta
Country
Italy
Facility Name
98
City
Napoli
Country
Italy
Facility Name
67
City
Prato
Country
Italy
Facility Name
36
City
Roma
Country
Italy
Facility Name
39
City
Verona
Country
Italy
Facility Name
194
City
Chihuahua
Country
Mexico
Facility Name
195
City
Chihuahua
Country
Mexico
Facility Name
193
City
Guadalajara
Country
Mexico
Facility Name
192
City
Monterrey
Country
Mexico
Facility Name
191
City
San Luis Potosi
Country
Mexico
Facility Name
60
City
Monaco
Country
Monaco
Facility Name
107
City
Bydgoszcz
Country
Poland
Facility Name
106
City
Poznan
Country
Poland
Facility Name
113
City
Warszawa
Country
Poland
Facility Name
115
City
Warszawa
Country
Poland
Facility Name
108
City
Wroclaw
Country
Poland
Facility Name
69
City
Coimbra
Country
Portugal
Facility Name
76
City
Lisboa
Country
Portugal
Facility Name
27
City
Lisbon
Country
Portugal
Facility Name
14
City
Ponte De Lima
Country
Portugal
Facility Name
81
City
Porto
Country
Portugal
Facility Name
54
City
Bacau
Country
Romania
Facility Name
74
City
Braila
Country
Romania
Facility Name
24
City
Bucharest
Country
Romania
Facility Name
25
City
Bucharest
Country
Romania
Facility Name
28
City
Bucharest
Country
Romania
Facility Name
32
City
Bucharest
Country
Romania
Facility Name
57
City
Bucharest
Country
Romania
Facility Name
12
City
Cluj-Napoca
Country
Romania
Facility Name
96
City
Galati
Country
Romania
Facility Name
26
City
Iasi
Country
Romania
Facility Name
16
City
A Coruna
Country
Spain
Facility Name
52
City
A Coruna
Country
Spain
Facility Name
30
City
Madrid
Country
Spain
Facility Name
83
City
Madrid
Country
Spain
Facility Name
82
City
Sabadell
Country
Spain
Facility Name
65
City
Vigo
Country
Spain
Facility Name
53
City
St. Gallen
Country
Switzerland
Facility Name
50
City
Zürich
Country
Switzerland
Facility Name
86
City
Ashford
Country
United Kingdom
Facility Name
78
City
Brighton
Country
United Kingdom
Facility Name
59
City
Leeds
Country
United Kingdom
Facility Name
19
City
London
Country
United Kingdom
Facility Name
77
City
Poole
Country
United Kingdom
Facility Name
55
City
Sheffield
Country
United Kingdom
Facility Name
73
City
Upton
Country
United Kingdom
Facility Name
99
City
Wigan
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27863807
Citation
Smolen JS, Burmester GR, Combe B, Curtis JR, Hall S, Haraoui B, van Vollenhoven R, Cioffi C, Ecoffet C, Gervitz L, Ionescu L, Peterson L, Fleischmann R. Head-to-head comparison of certolizumab pegol versus adalimumab in rheumatoid arthritis: 2-year efficacy and safety results from the randomised EXXELERATE study. Lancet. 2016 Dec 3;388(10061):2763-2774. doi: 10.1016/S0140-6736(16)31651-8. Epub 2016 Nov 15. Erratum In: Lancet. 2017 Feb 4;389(10068):e2.
Results Reference
result
PubMed Identifier
32100960
Citation
Paul S, Marotte H, Kavanaugh A, Goupille P, Kvien TK, de Longueville M, Mulleman D, Sandborn WJ, Vande Casteele N. Exposure-Response Relationship of Certolizumab Pegol and Achievement of Low Disease Activity and Remission in Patients With Rheumatoid Arthritis. Clin Transl Sci. 2020 Jul;13(4):743-751. doi: 10.1111/cts.12760. Epub 2020 Apr 1.
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

Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate

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