The Long-term Safety and Efficacy of Olokizumab (CDP6038) With Active Rheumatoid Arthritis
This study is ongoing, but not recruiting participants.
Sponsor:
UCB, Inc.
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01533714
First received: February 10, 2012
Last updated: April 8, 2013
Last verified: April 2013
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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 ]
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | November 2017 |
| Estimated Primary Completion Date: | November 2017 (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
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: | April 8, 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 June 17, 2013