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

This study has been completed.
Sponsor:
Collaborator:
UCB Japan Co. Ltd.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00850343
First received: February 23, 2009
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Certolizumab pegol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Number of Participants With Adverse Events [ 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. ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks) ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks) ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks) ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks) ] [ Designated as safety issue: No ]

    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) [ Time Frame: Baseline (of Study 275-08-003), Week 0 (of this study) and Week 100 ] [ Designated as safety issue: No ]

    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).



Enrollment: 208
Study Start Date: March 2009
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Certolizumab pegol 200 mg
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.
Drug: Certolizumab pegol
Subcutaneous (SC) injection
Other Names:
  • Cimzia
  • CDP870
Experimental: Certolizumab pegol 400 mg
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.
Drug: Certolizumab pegol
Subcutaneous (SC) injection
Other Names:
  • Cimzia
  • CDP870

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00850343

Locations
Japan
Chubu Region, Japan
Chugoku Region, Japan
Hokkaido Region, Japan
Kanto Region, Japan
Kinki Region, Japan
Kyushu Region, Japan
Shikoku Region, Japan
Tohoku Region, Japan
Sponsors and Collaborators
Astellas Pharma Inc
UCB Japan Co. Ltd.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00850343     History of Changes
Other Study ID Numbers: CDP870-275-08-004, JapicCTI-090701
Study First Received: February 23, 2009
Results First Received: September 9, 2014
Last Updated: September 25, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:
Rheumatoid Arthritis
Certolizumab Pegol
Cimzia

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Certolizumab pegol
Immunoglobulin Fab Fragments
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014