Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients

Rheumatoid Arthritis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00850343
• Other study ID #: CDP870-275-08-004
• Secondary ID: JapicCTI-090701
• Status: Completed
• Phase: Phase 3
• First received: February 23, 2009
• Last updated: October 27, 2014
• Start date: March 2009
• Est. completion date: May 2013

Study information

• Verified date: October 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Description:

This study was initiated by Otsuka Pharmaceutical Co., Ltd and transferred to Astellas on 12/04/2012.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Certolizumab pegol
Subcutaneous (SC) injection

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	UCB Japan Co. Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	Yes
Secondary	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).	Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)	No
Secondary	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).	Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)	No
Secondary	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).	Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)	No
Secondary	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.	Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)	No
Secondary	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).	Baseline (of Study 275-08-003), Week 0 (of this study) and Week 100	No