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A Study of the Safety and Effectiveness of Liquid Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Certolizumab Pegol

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, CDP870, Certolizumab Pegol, Cimzia

Eligibility Criteria

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

Inclusion Criteria: Patients must have either failed to achieve an American College of Rheumatology 20 % (ACR20) response at Weeks 12 and 14 in C87050 [NCT00160602], or must have completed the entire Week 24 assessment of C87050 [NCT00160602] trial. Exclusion Criteria: A diagnosis of any other inflammatory Arthritis (e.g. Psoriatic Arthritis or Ankylosing Spondylitis) A secondary, non-inflammatory type of Arthritis (e.g. Osteoarthritis or Fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of CDP870 on the patient's primary diagnosis of Rheumatoid Arthritis (RA) Any concomitant biological therapy Any experimental therapy, within or outside a clinical

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Certolizumab Pegol

Arm Description

All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.

Outcomes

Primary Outcome Measures

Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years

An 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. First dose of CZP was at Baseline of the preceding double-blind study NCT00160602 for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.

Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years

A SAE is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires in patient hospitalisation or prolongation of existing hospitalisation Results in persistent or significant disability/incapacity, or Is a congenital anomaly or birth defect Is as infection that requires treatment parenteral antibiotics Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above First dose of CZP was at Baseline of the preceding double-blind study NCT00160602 for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.

Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study

An 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. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms.

Secondary Outcome Measures

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52

The assessments are based on a 20 % or greater improvement from Baseline to Week 52 in the number of tender joints, a 20 % or more improvement 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). Baseline is Baseline of the preceding double-blind study.

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 100

The assessments are based on a 20 % or greater improvement from Baseline to Week 100 in the number of tender joints, a 20 % or more improvement 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). Baseline is Baseline of the preceding double-blind study.

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 148

The assessments are based on a 20 % or greater improvement from Baseline to Week 148 in the number of tender joints, a 20 % or more improvement 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). Baseline is Baseline of the preceding double-blind study.

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 196

The assessments are based on a 20 % or greater improvement from Baseline to Week 196 in the number of tender joints, a 20 % or more improvement 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). Baseline is Baseline of the preceding double-blind study.

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 244

The assessments are based on a 20 % or greater improvement from Baseline to Week 244 in the number of tender joints, a 20 % or more improvement 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). Baseline is Baseline of the preceding double-blind study.

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal

The assessments are based on a 20 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 20 % or more improvement 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). Baseline is Baseline of the preceding double-blind study.

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52

The assessments are based on a 50 % or greater improvement from Baseline to Week 52 in the number of tender joints, a 50 % or more improvement 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). Baseline is Baseline of the preceding double-blind study.

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 100

The assessments are based on a 50 % or greater improvement from Baseline to Week 100 in the number of tender joints, a 50 % or more improvement 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). Baseline is Baseline of the preceding double-blind study.

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 148

The assessments are based on a 50 % or greater improvement from Baseline to Week 148 in the number of tender joints, a 50 % or more improvement 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). Baseline is Baseline of the preceding double-blind study.

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 196

The assessments are based on a 50 % or greater improvement from Baseline to Week 196 in the number of tender joints, a 50 % or more improvement 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). Baseline is Baseline of the preceding double-blind study.

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 244

The assessments are based on a 50 % or greater improvement from Baseline to Week 244 in the number of tender joints, a 50 % or more improvement 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). Baseline is Baseline of the preceding double-blind study.

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal

The assessments are based on a 50 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 50 % or more improvement 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). Baseline is Baseline of the preceding double-blind study.

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52

The assessments are based on a 70 % or greater improvement from Baseline to Week 52 in the number of tender joints, a 70 % or more improvement 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). Baseline is Baseline of the preceding double-blind study.

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 100

The assessments are based on a 70 % or greater improvement from Baseline to Week 100 in the number of tender joints, a 70 % or more improvement 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). Baseline is Baseline of the preceding double-blind study.

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 148

The assessments are based on a 70 % or greater improvement from Baseline to Week 148 in the number of tender joints, a 70 % or more improvement 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). Baseline is Baseline of the preceding double-blind study.

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 196

The assessments are based on a 70 % or greater improvement from Baseline to Week 196 in the number of tender joints, a 70 % or more improvement 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). Baseline is Baseline of the preceding double-blind study.

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 244

The assessments are based on a 70 % or greater improvement from Baseline to Week 244 in the number of tender joints, a 70 % or more improvement 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). Baseline is Baseline of the preceding double-blind study.

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal

The assessments are based on a 70 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 70 % or more improvement 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). Baseline is Baseline of the preceding double-blind study.

Change From Baseline of the Preceding Double-Blind Study to Week 104 in Modified Total Sharp Score (mTSS)

The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively, as assessed by x-rays of the hands and feet. The score ranges from 0 to 448 with higher scores representing greater damage. A negative value in mTSS change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.

Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire - Disability Index (HAQ-DI) Total Score

The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.

Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness

Morning stiffness is defined as the time in hours elapsed between the time of usual awakening (even if not in the morning) and the time the subject is as limber as he/she will be during a day involving typical activities. A negative value in duration of morning stiffness change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.

Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR])

DAS28[ESR] is 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 (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline.

Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit

Good EULAR response is defined as DAS28[ESR] improvement from Baseline of the preceding double-blind study > 1.2 and DAS28[ESR] value < 3.2.

Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score

The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept PCS score are scored to yield values between 0 (worst) and 100 (best).

Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score

The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept MCS score are scored to yield values between 0 (worst) and 100 (best).

Full Information

NCT ID

NCT00160641

First Posted

September 8, 2005

Last Updated

March 16, 2020

Sponsor

UCB Pharma

1. Study Identification

Unique Protocol Identification Number

NCT00160641

Brief Title

A Study of the Safety and Effectiveness of Liquid Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis

Official Title

A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis Who Participated in Study CDP870-050

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

November 2005 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UCB Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

An open ended study in which patients who completed the preceding double-blind study NCT00160602 are given Certolizumab Pegol and assessed for signs and symptoms of Rheumatoid Arthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, CDP870, Certolizumab Pegol, Cimzia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

567 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Certolizumab Pegol

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Certolizumab Pegol

Other Intervention Name(s)

Cimzia

Intervention Description

Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.

Primary Outcome Measure Information:

Title

Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years

Description

Time Frame

From first dose of CZP to the end of the open-label study (approximately 6.8 years)

Title

Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years

Description

Time Frame

From first dose of CZP to the end of the open-label study (approximately 6.8 years)

Title

Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study

Description

An 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. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms.

Time Frame

From Entry Visit (Week 0) to the end of the study (approximately 6.3 years)

Secondary Outcome Measure Information:

Title

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52

Description

Time Frame

From Baseline of the preceding double-blind study to Week 52 of the open-label study

Title

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 100

Description

Time Frame

From Baseline of the preceding double-blind study to Week 100 of the open-label study

Title

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 148

Description

Time Frame

From Baseline of the preceding double-blind study to Week 148 of the open-label study

Title

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 196

Description

Time Frame

From Baseline of the preceding double-blind study to Week 196 of the open-label study

Title

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 244

Description

Time Frame

From Baseline of the preceding double-blind study to Week 244 of the open-label study

Title

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal

Description

Time Frame

From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)

Title

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52

Description

Time Frame

From Baseline of the preceding double-blind study to Week 52 of the open-label study

Title

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 100

Description

Time Frame

From Baseline of the preceding double-blind study to Week 100 of the open-label study

Title

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 148

Description

Time Frame

From Baseline of the preceding double-blind study to Week 148 of the open-label study

Title

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 196

Description

Time Frame

From Baseline of the preceding double-blind study to Week 196 of the open-label study

Title

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 244

Description

Time Frame

From Baseline of the preceding double-blind study to Week 244 of the open-label study

Title

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal

Description

Time Frame

From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)

Title

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52

Description

Time Frame

From Baseline of the preceding double-blind study to Week 52 of the open-label study

Title

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 100

Description

Time Frame

From Baseline of the preceding double-blind study to Week 100 of the open-label study

Title

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 148

Description

Time Frame

From Baseline of the preceding double-blind study to Week 148 of the open-label study

Title

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 196

Description

Time Frame

From Baseline of the preceding double-blind study to Week 196 of the open-label study

Title

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 244

Description

Time Frame

From Baseline of the preceding double-blind study to Week 244 of the open-label study

Title

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal

Description

Time Frame

From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)

Title

Change From Baseline of the Preceding Double-Blind Study to Week 104 in Modified Total Sharp Score (mTSS)

Description

Time Frame

From Baseline of the preceding double-blind study to Week 104 of the open-label study

Title

Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire - Disability Index (HAQ-DI) Total Score

Description

Time Frame

From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)

Title

Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness

Description

Time Frame

From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)

Title

Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR])

Description

Time Frame

From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)

Title

Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit

Description

Good EULAR response is defined as DAS28[ESR] improvement from Baseline of the preceding double-blind study > 1.2 and DAS28[ESR] value < 3.2.

Time Frame

From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)

Title

Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score

Description

Time Frame

From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)

Title

Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score

Description

The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept MCS score are scored to yield values between 0 (worst) and 100 (best).

Time Frame

From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

UCB Clinical Trial Call Center

Organizational Affiliation

+1 877 822 9493 (UCB)

Official's Role

Study Director

Facility Information:

Facility Name

172

City

Palm Desert

State/Province

California

Country

United States

Facility Name

185

City

Pasadena

State/Province

California

Country

United States

Facility Name

170

City

Santa Maria

State/Province

California

Country

United States

Facility Name

194

City

Whittier

State/Province

California

Country

United States

Facility Name

176

City

Naples

State/Province

Florida

Country

United States

Facility Name

186

City

Palm Harbor

State/Province

Florida

Country

United States

Facility Name

188

City

Kansas City

State/Province

Missouri

Country

United States

Facility Name

182

City

Saint Louis

State/Province

Missouri

Country

United States

Facility Name

178

City

Stratford

State/Province

New Jersey

Country

United States

Facility Name

192

City

Amarillo

State/Province

Texas

Country

United States

Facility Name

173

City

Austin

State/Province

Texas

Country

United States

Facility Name

175

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

303

City

Pleven

Country

Bulgaria

Facility Name

302

City

Sofia

Country

Bulgaria

Facility Name

500

City

Rijeka

Country

Croatia

Facility Name

600

City

Brno

Country

Czechia

Facility Name

603

City

Hlucin

Country

Czechia

Facility Name

606

City

Praha 2

Country

Czechia

Facility Name

605

City

Praha 5

Country

Czechia

Facility Name

604

City

Sokolov

Country

Czechia

Facility Name

602

City

Uherske Hradiste

Country

Czechia

Facility Name

607

City

Zlin

Country

Czechia

Facility Name

700

City

Tallinn

Country

Estonia

Facility Name

802

City

Afula

Country

Israel

Facility Name

805

City

Ashkelon

Country

Israel

Facility Name

807

City

Haifa

Country

Israel

Facility Name

804

City

Jerusalem

Country

Israel

Facility Name

801

City

Ramat Gan

Country

Israel

Facility Name

806

City

Zerifin

Country

Israel

Facility Name

901

City

Daugavpils

Country

Latvia

Facility Name

900

City

Riga

Country

Latvia

Facility Name

103

City

Alytus

Country

Lithuania

Facility Name

100

City

Kaunas

Country

Lithuania

Facility Name

102

City

Klaipeda

Country

Lithuania

Facility Name

101

City

Siauliai

Country

Lithuania

Facility Name

124

City

Bialystok

Country

Poland

Facility Name

120

City

Elblag

Country

Poland

Facility Name

123

City

Krakow

Country

Poland

Facility Name

125

City

Lublin

Country

Poland

Facility Name

121

City

Sopot

Country

Poland

Facility Name

122

City

Torun

Country

Poland

Facility Name

150

City

Moscow

Country

Russian Federation

Facility Name

151

City

Moscow

Country

Russian Federation

Facility Name

156

City

Moscow

Country

Russian Federation

Facility Name

159

City

Moscow

Country

Russian Federation

Facility Name

152

City

St. Petersburg

Country

Russian Federation

Facility Name

154

City

St. Petersburg

Country

Russian Federation

Facility Name

155

City

St. Petersburg

Country

Russian Federation

Facility Name

158

City

St. Petersburg

Country

Russian Federation

Facility Name

153

City

Yaroslavl

Country

Russian Federation

Facility Name

132

City

Belgrade

Country

Serbia

Facility Name

133

City

Belgrade

Country

Serbia

Facility Name

131

City

Niska Banja

Country

Serbia

Facility Name

141

City

Kosice

Country

Slovakia

Facility Name

143

City

Kosice

Country

Slovakia

Facility Name

140

City

Piestany

Country

Slovakia

Facility Name

142

City

Piestany

Country

Slovakia

Facility Name

162

City

Dnepropetrovsk

Country

Ukraine

Facility Name

161

City

Donetsk

Country

Ukraine

Facility Name

168

City

Donetsk

Country

Ukraine

Facility Name

165

City

Ivano-Frankivsk

Country

Ukraine

Facility Name

163

City

Kiev

Country

Ukraine

Facility Name

164

City

Kiev

Country

Ukraine

Facility Name

167

City

Kiev

Country

Ukraine

Facility Name

169

City

Kiev

Country

Ukraine

Facility Name

160

City

Simferopol

Country

Ukraine

Facility Name

166

City

Zaporozhye

Country

Ukraine

12. IPD Sharing Statement

Citations:

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

background

PubMed Identifier

29246162

Citation

Curtis JR, Winthrop K, O'Brien C, Ndlovu MN, de Longueville M, Haraoui B. Use of a baseline risk score to identify the risk of serious infectious events in patients with rheumatoid arthritis during certolizumab pegol treatment. Arthritis Res Ther. 2017 Dec 15;19(1):276. doi: 10.1186/s13075-017-1466-y.

Results Reference

derived

PubMed Identifier

26353833

Citation

Smolen JS, van Vollenhoven R, Kavanaugh A, Strand V, Vencovsky J, Schiff M, Landewe R, Haraoui B, Arendt C, Mountian I, Carter D, van der Heijde D. Certolizumab pegol plus methotrexate 5-year results from the rheumatoid arthritis prevention of structural damage (RAPID) 2 randomized controlled trial and long-term extension in rheumatoid arthritis patients. Arthritis Res Ther. 2015 Sep 10;17(1):245. doi: 10.1186/s13075-015-0767-2.

Results Reference

derived

Links:

URL

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

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