The Long-term Safety and Efficacy of Olokizumab (CDP6038) With Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01533714
First received: February 10, 2012
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

The primary objective of this study is to assess the long-term safety of CDP6038.


Condition Intervention Phase
Rheumatoid Arthritis
Biological: Olokizumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-center, Open-label, Follow-up Study to Assess the Long-term Safety and Efficacy of CDP6038 Administered Subcutaneously to Asian Subjects With Active Rheumatoid Arthritis Who Completed Study RA0083

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Number of a treatment Emergent Adverse Events (TEAEs) during the entire Treatment Period (approximately 250 weeks) [ Time Frame: From entry Week 0 (Visit 1) through end of treatment (up to approximately 250 weeks) ] [ Designated as safety issue: No ]
  • Number of subjects reporting at least 1 Adverse Event (AE) during the entire Treatment Period (approximately 250 weeks) [ Time Frame: From entry Week 0 (Visit 1) through end of treatment (up to approximately 250 weeks) ] [ Designated as safety issue: No ]
  • Change from Baseline in the Disease Activity Score 28-joint count (C-reactive protein) (DAS28[CRP]) at Week 24 [ Time Frame: From Baseline (Week 0 of RA0083 [NCT01463059]) to Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in the Disease Activity Score 28-joint count (C-reactive protein) (DAS28[CRP]) at Week 12 [ Time Frame: From Baseline (Week 0 of RA0083 [NCT01463059]) to Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in the Disease Activity Score 28-joint count (C-reactive protein) (DAS28[CRP]) at Week 48 [ Time Frame: From Baseline (Week 0 of RA0083 [NCT01463059]) to Week 48 ] [ Designated as safety issue: No ]
  • Change from Baseline in the Disease Activity Score 28-joint count (C-reactive protein) (DAS28[CRP]) at Week 96 [ Time Frame: From Baseline (Week 0 of RA0083 [NCT01463059]) to Week 96 ] [ Designated as safety issue: No ]
  • Number of responders in American College of Rheumatology 20% Response Criteria (ACR20) at Week 24 [ Time Frame: From Baseline (Week 0 of RA0083 [NCT01463059]) to Week 24 ] [ Designated as safety issue: No ]
    Number of subjects who achieve ACR 20 will be calculated at Week 24. The calculation is based on the improvement from the Baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards.

  • Number of responders in American College of Rheumatology 20% Response Criteria (ACR20) at Week 48 [ Time Frame: From Baseline (Week 0 of RA0083 [NCT01463059]) to Week 48 ] [ Designated as safety issue: No ]
    Number of subjects who achieve ACR 20 will be calculated at Week 48. The calculation is based on the improvement from the Baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards.

  • Number of responders in American College of Rheumatology 20% Response Criteria (ACR20) at Week 96 [ Time Frame: From Baseline (Week 0 of RA0083 [NCT01463059]) to Week 96 ] [ Designated as safety issue: No ]
    Number of subjects who achieve ACR 20 will be calculated at Week 96. The calculation is based on the improvement from the Baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards.

  • Number of responders in American College of Rheumatology 50% Response Criteria (ACR50) at Week 24 [ Time Frame: From Baseline (Week 0 of RA0083 [NCT01463059]) to Week 24 ] [ Designated as safety issue: No ]
    Number of subjects who achieve ACR 50 will be calculated at Week 24. The calculation is based on the improvement from the Baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards.

  • Number of responders in American College of Rheumatology 50% Response Criteria (ACR50) at Week 48 [ Time Frame: From Baseline (Week 0 of RA0083 [NCT01463059]) to Week 48 ] [ Designated as safety issue: No ]
    Number of subjects who achieve ACR 50 will be calculated at Week 48. The calculation is based on the improvement from the Baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards.

  • Number of responders in American College of Rheumatology 50% Response Criteria (ACR50) at Week 96 [ Time Frame: From Baseline (Week 0 of RA0083 [NCT01463059]) to Week 96 ] [ Designated as safety issue: No ]
    Number of subjects who achieve ACR 50 will be calculated at Week 96. The calculation is based on the improvement from the Baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards.

  • Number of responders in American College of Rheumatology 70% Response Criteria (ACR70) at Week 24 [ Time Frame: From Baseline (Week 0 of RA0083 [NCT01463059]) to Week 24 ] [ Designated as safety issue: No ]
    Number of subjects who achieve ACR 70 will be calculated at Week 24. The calculation is based on the improvement from the Baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards.

  • Number of responders in American College of Rheumatology 70% Response Criteria (ACR70) at Week 48 [ Time Frame: From Baseline (Week 0 of RA0083 [NCT01463059]) to Week 48 ] [ Designated as safety issue: Yes ]
    Number of subjects who achieve ACR 70 will be calculated at Week 48. The calculation is based on the improvement from the Baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards.

  • Number of responders in American College of Rheumatology 70% Response Criteria (ACR70) at Week 96 [ Time Frame: From Baseline (Week 0 of RA0083 [NCT01463059]) to Week 96 ] [ Designated as safety issue: No ]
    Number of subjects who achieve ACR 70 will be calculated at Week 96. The calculation is based on the improvement from the Baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards.

  • Percentage of subjects with DAS28(CRP) < 2.6 at Week 12 [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]
    DAS28: Disease Activity Score 28-joint count CRP: C-reactive protein

  • Percentage of subjects with DAS28(CRP) < 2.6 at Week 24 [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
  • Percentage of subjects with DAS28(CRP) < 2.6 at Week 48 [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
  • Percentage of subjects with DAS28(CRP) < 2.6 at Week 96 [ Time Frame: At Week 96 ] [ Designated as safety issue: No ]
  • Percentage of subjects with DAS28(CRP) ≤ 3.2 at Week 12 [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]
    DAS28: Disease Activity Score 28-joint count CRP: C-reactive protein

  • Percentage of subjects with DAS28(CRP) ≤ 3.2 at Week 24 [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
  • Percentage of subjects with DAS28(CRP) ≤ 3.2 at Week 48 [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
  • Percentage of subjects with DAS28(CRP) ≤ 3.2 at Week 96 [ Time Frame: At Week 96 ] [ Designated as safety issue: No ]
  • Change from Baseline (Week 0 of RA0083 [NCT01463059]) in Clinical Disease Activity Index (CDAI) at Week 48 [ Time Frame: From Baseline (Week 0 of RA0083 [NCT01463059]) to Week 48 ] [ Designated as safety issue: No ]
  • Change from Baseline (Week 0 of RA0083 [NCT01463059]) in CDAI at Week 96 [ Time Frame: From Baseline (Week 0 of RA0083 [NCT01463059]) to Week 96 ] [ Designated as safety issue: No ]
  • Change from Baseline (Week 0 of RA0083 [NCT01463059]) in Simplified Disease Activity Index (SDAI) at Week 48 [ Time Frame: From Baseline (Week 0 of RA0083 [NCT01463059]) to Week 48 ] [ Designated as safety issue: No ]
  • Change from Baseline (Week 0 of RA0083 [NCT01463059]) in SDAI at Week 96 [ Time Frame: From Baseline (Week 0 of RA0083 [NCT01463059]) to Week 96 ] [ Designated as safety issue: No ]
  • Plasma concentration of CDP6038 at Week 4 [ Time Frame: At Week 4 ] [ Designated as safety issue: No ]
  • Plasma concentration of CDP6038 at Week 8 [ Time Frame: At Week 8 ] [ Designated as safety issue: No ]
  • Plasma concentration of CDP6038 at Week 12 [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]
  • Plasma concentration of CDP6038 at Week 16 [ Time Frame: At Week 16 ] [ Designated as safety issue: No ]
  • Plasma concentration of CDP6038 at Week 24 [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
  • Plasma concentration of CDP6038 at Week 32 [ Time Frame: At Week 32 ] [ Designated as safety issue: No ]
  • Plasma concentration of CDP6038 at Week 40 [ Time Frame: At Week 40 ] [ Designated as safety issue: No ]
  • Plasma concentration of CDP6038 at Week 48 [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
  • Plasma concentration of CDP6038 at Week 72 [ Time Frame: At Week 72 ] [ Designated as safety issue: No ]
  • Plasma concentration of CDP6038 at Week 96 [ Time Frame: At Week 96 ] [ Designated as safety issue: No ]
  • Plasma concentration of CDP6038 at Week 120 [ Time Frame: At Week 120 ] [ Designated as safety issue: No ]
  • Plasma concentration of CDP6038 at study completion [ Time Frame: At study completion ] [ Designated as safety issue: No ]
  • Plasma concentration of Anti-CDP6038 antibodies at Week 4 [ Time Frame: At Week 4 ] [ Designated as safety issue: No ]
  • Plasma concentration of Anti-CDP6038 antibodies at Week 8 [ Time Frame: At Week 8 ] [ Designated as safety issue: No ]
  • Plasma concentration of Anti-CDP6038 antibodies at Week 12 [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]
  • Plasma concentration of Anti-CDP6038 antibodies at Week 16 [ Time Frame: At Week 16 ] [ Designated as safety issue: No ]
  • Plasma concentration of Anti-CDP6038 antibodies at Week 24 [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
  • Plasma concentration of Anti-CDP6038 antibodies at Week 32 [ Time Frame: At Week 32 ] [ Designated as safety issue: No ]
  • Plasma concentration of Anti-CDP6038 antibodies at Week 40 [ Time Frame: At Week 40 ] [ Designated as safety issue: No ]
  • Plasma concentration of Anti-CDP6038 antibodies at Week 48 [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
  • Plasma concentration of Anti-CDP6038 antibodies at Week 72 [ Time Frame: At Week 72 ] [ Designated as safety issue: No ]
  • Plasma concentration of Anti-CDP6038 antibodies at Week 96 [ Time Frame: At Week 96 ] [ Designated as safety issue: No ]
  • Plasma concentration of Anti-CDP6038 antibodies at Week 120 [ Time Frame: At Week 120 ] [ Designated as safety issue: No ]
  • Plasma concentration of Anti-CDP6038 antibodies at study completion [ Time Frame: At study completion ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: January 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olokizumab 120 mg
Olokizumab 120 mg : subcutaneous injections at q2w (every two weeks).
Biological: Olokizumab

Solution for injection with a concentration of Olokizumab of 100 mg/mL Subjects will receive CDP6038 at a dose of 120 mg every two weeks.

This study will continue until approval of the marketing application for the indication of RA in the subject's country or region or until further notice from UCB.


Detailed Description:

Eligible subjects will enter the study after completing the Week 12 Visit of RA0083 [NCT01463059] and will be allowed to continue in this open-label study until approval of the marketing application for the indication of Rheumatoid Arthritis (RA) in the subject's country or region, or until further notice from UCB. All subjects will receive subcutaneous (sc) injections of CDP6038 120 mg every 2 weeks (q2w) throughout the study, regardless of their treatment assignment in RA0083 [NCT01463059].

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completed the RA0083 [NCT01463059] study (Week 12 Visit)
  • Must have maintained their stable dose (and route) of methotrexate (MTX) between 6 to 16 mg/week in Japan or 7.5 to 20 mg/week in Korea and Taiwan in RA0083 [NCT01463059], and plan to maintain this same dose and route of administration for at least 12 weeks
  • Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing 2 acceptable methods of contraception

Exclusion Criteria:

  • Have an ongoing SAE from the RA0083 [NCT01463059] study
  • Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the study or within 24 weeks
  • Have evidence of active or latent tuberculosis (TB)
  • Subject is receiving any biologic response modifier or synthetic disease-modifying antirheumatic drug (DMARD) other than MTX
  • Subject has planned surgery during the first 12 weeks of the study
  • Subjects who tested positive for hepatitis B core antibody (HBcAb) and/or hepatitis B surface antibody (HBsAb) at Screening in RA0083 [NCT01463059] and who subsequently test positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) at Week 12 of RA0083 [NCT01463059]
  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: NCT01533714

Locations
Japan
102
Chiba, Japan
114
Fukuoka, Japan
115
Fukuoka, Japan
113
Hiroshima, Japan
120
Kakogawa, Japan
118
Kumamoto, Japan
116
Kurume, Japan
122
Matsuyama, Japan
107
Nagaoka, Japan
110
Nagoya, Japan
103
Narita, Japan
119
Oita, Japan
112
Okayama, Japan
100
Sapporo, Japan
117
Sasebo, Japan
123
Tokyo, Japan
101
Tomakomai, Japan
108
Tonami, Japan
111
Tsu, Japan
105
Yokohama, Japan
104
Yotukaido, Japan
Korea, Republic of
200
Daejeon, Korea, Republic of
201
Jung-Gu, Korea, Republic of
202
Seongdong-Gu, Korea, Republic of
203
Seoul, Korea, Republic of
204
Seoul, Korea, Republic of
Taiwan
301
Taichung, Taiwan
306
Taichung, Taiwan
307
Taichung, Taiwan
302
Taipei, Taiwan
308
Taipei, Taiwan
309
Taipei, Taiwan
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01533714     History of Changes
Other Study ID Numbers: RA0089
Study First Received: February 10, 2012
Last Updated: December 16, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan : Food and Drug Administration

Keywords provided by UCB, Inc.:
Rheumatoid Arthritis
Monoclonal antibody
Interleukin-6
Olokizumab
CDP6038

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 23, 2014