Back to resultsLong-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Certolizumab pegol
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Certolizumab Pegol, Cimzia
Eligibility Criteria
Inclusion Criteria:
Subjects who participated in Study 275-08-003 and meet all of the criteria described below.
- Patients who did not reach ACR20, and prematurely discontinued Study 275-08-003 at Week 16 or completed Study 275-08-003 by Week 24.
Exclusion Criteria:
- Patients who experienced an important protocol deviation as mentioned below during Study 275-08-003.
- Patients who received live or attenuated vaccines during Study 275-08-003 (Except for influenza or pneumococcal vaccines).
- Patients who were found to have tuberculosis on a chest X-ray during Study 275-08-003.
- Patients who required treatment for the same infection at two or more different times during Study 275-08-003
- Women who are pregnant, are lactating, of childbearing potential and wish to conceive during the study and post-study 3 months.
- Patients whom the investigator has decided to be inappropriate for participation in the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Certolizumab pegol 200 mg
Certolizumab pegol 400 mg
Arm Description
Participants received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Participants received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events
An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which did not necessarily have a causal relationship with the treatment. In this study, events that occurred between the time of informed consent and the start of study medication were included in the adverse events for Study 275-08-003. Any event existing prior to the initiation of study treatment that was aggravated after initiation of study treatment was handled as a new event. The investigator assessed the severity of each AE as follows:
Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities.
A serious adverse event is an AE that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect.
Secondary Outcome Measures
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response
A participant was an ACR20 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:
≥ 20% improvement in 68 tender joint count;
≥ 20% improvement in 66 swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein (CRP).
Percentage of Participants With American College of Rheumatology 50% (ACR50) Response
A participant was an ACR50 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:
≥ 50% improvement in 68 tender joint count;
≥ 50% improvement in 66 swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein (CRP).
Percentage of Participants With American College of Rheumatology 70% (ACR70) Response
A participant was an ACR70 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:
≥ 70% improvement in 68 tender joint count;
≥ 70% improvement in 66 swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein (CRP).
Change From Baseline in Disease Activity Score (DAS) 28
The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count;
28 swollen joint count;
Erythrocyte sedimentation rate (ESR);
Patient's global assessment of disease activity.
To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.
The data before study drug administration of 275-08-003 Study was utilized for Baseline.
DAS28(ESR) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible ESR. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score of 3.2 or less indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.
Change From Baseline in Modified Total Sharp Score (mTSS)
X-ray images of extremities (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by at least two radiographic readers.
The degree of joint destruction was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints.
The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst).
Full Information
NCT ID
NCT00850343
First Posted
February 23, 2009
Last Updated
October 27, 2014
Sponsor
Astellas Pharma Inc
Collaborators
UCB Japan Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00850343
Brief Title
Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients
Official Title
A Multicenter, Open-label, Long-term Safety Study of CDP870 to Evaluate the Safety and Efficacy of CDP870 Administered Without Coadministration of Methotrexate (MTX) Over the Long Term in Patients With Active Rheumatoid Arthritis Transferred From the Efficacy Confirmatory Study (Study 275-08-003)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
UCB Japan Co. Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objectives of this study are to evaluate the safety and efficacy of certolizumab pegol when administered without coadministration of methotrexate over the long term in Japanese RA patients who transferred from Study 275-08-003 (NCT00791921), and to evaluate the effects of different dosing regimens on the safety and efficacy of certolizumab pegol in American College of Rheumatology 20% (ACR20) responders who completed Study 275-08-003.
Detailed Description
This study was initiated by Otsuka Pharmaceutical Co., Ltd and transferred to Astellas on 12/04/2012.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Certolizumab Pegol, Cimzia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Certolizumab pegol 200 mg
Arm Type
Experimental
Arm Description
Participants received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Arm Title
Certolizumab pegol 400 mg
Arm Type
Experimental
Arm Description
Participants received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Intervention Type
Drug
Intervention Name(s)
Certolizumab pegol
Other Intervention Name(s)
Cimzia, CDP870
Intervention Description
Subcutaneous (SC) injection
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which did not necessarily have a causal relationship with the treatment. In this study, events that occurred between the time of informed consent and the start of study medication were included in the adverse events for Study 275-08-003. Any event existing prior to the initiation of study treatment that was aggravated after initiation of study treatment was handled as a new event. The investigator assessed the severity of each AE as follows:
Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities.
A serious adverse event is an AE that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect.
Time Frame
From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
Secondary Outcome Measure Information:
Title
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response
Description
A participant was an ACR20 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:
≥ 20% improvement in 68 tender joint count;
≥ 20% improvement in 66 swollen joint count; and
≥ 20% improvement in at least 3 of the 5 following parameters:
Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein (CRP).
Time Frame
Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
Title
Percentage of Participants With American College of Rheumatology 50% (ACR50) Response
Description
A participant was an ACR50 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:
≥ 50% improvement in 68 tender joint count;
≥ 50% improvement in 66 swollen joint count; and
≥ 50% improvement in at least 3 of the 5 following parameters:
Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein (CRP).
Time Frame
Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
Title
Percentage of Participants With American College of Rheumatology 70% (ACR70) Response
Description
A participant was an ACR70 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:
≥ 70% improvement in 68 tender joint count;
≥ 70% improvement in 66 swollen joint count; and
≥ 70% improvement in at least 3 of the 5 following parameters:
Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);
Patient's global assessment of disease activity (measured on a 100 mm VAS);
Physician's global assessment of disease activity (measured on a 100 mm VAS);
Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
C-Reactive Protein (CRP).
Time Frame
Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
Title
Change From Baseline in Disease Activity Score (DAS) 28
Description
The DAS28 measures the severity of disease at a specific time and is derived from the following variables:
28 tender joint count;
28 swollen joint count;
Erythrocyte sedimentation rate (ESR);
Patient's global assessment of disease activity.
To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.
The data before study drug administration of 275-08-003 Study was utilized for Baseline.
DAS28(ESR) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible ESR. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score of 3.2 or less indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.
Time Frame
Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)
Title
Change From Baseline in Modified Total Sharp Score (mTSS)
Description
X-ray images of extremities (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by at least two radiographic readers.
The degree of joint destruction was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints.
The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst).
Time Frame
Baseline (of Study 275-08-003), Week 0 (of this study) and Week 100
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who participated in Study 275-08-003 and meet all of the criteria described below.
Patients who did not reach ACR20, and prematurely discontinued Study 275-08-003 at Week 16 or completed Study 275-08-003 by Week 24.
Exclusion Criteria:
Patients who experienced an important protocol deviation as mentioned below during Study 275-08-003.
Patients who received live or attenuated vaccines during Study 275-08-003 (Except for influenza or pneumococcal vaccines).
Patients who were found to have tuberculosis on a chest X-ray during Study 275-08-003.
Patients who required treatment for the same infection at two or more different times during Study 275-08-003
Women who are pregnant, are lactating, of childbearing potential and wish to conceive during the study and post-study 3 months.
Patients whom the investigator has decided to be inappropriate for participation in the study
Facility Information:
City
Chubu Region
Country
Japan
City
Chugoku Region
Country
Japan
City
Hokkaido Region
Country
Japan
City
Kanto Region
Country
Japan
City
Kinki Region
Country
Japan
City
Kyushu Region
Country
Japan
City
Shikoku Region
Country
Japan
City
Tohoku Region
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients
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