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

NCT01533714 | Terminated Phase 2 Results

• 1 other identifier: RA0089
• Study Type: interventional
• Target: 103
• Locations: 3 countries
• Sites: 32

Brief Summary

The purpose of this study is to evaluate the long-term safety and tolerability of CDP6038 (olokizumab) treatment in adult subjects with active rheumatoid arthritis (RA) who completed study RA0083 \[NCT01463059\].

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Monoclonal antibody; Interleukin-6; Olokizumab; CDP6038

Outcome Measures

Primary Outcomes (1)

• Total Number of Subjects With Treatment-emergent Adverse Events (TEAEs)

  Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.

  From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)

Secondary Outcomes (30)

• Change From Baseline (Week 0 of Study RA0083) in the Disease Activity Score-28-joint Count (C-reactive Protein) (DAS28[CRP]) at Week 12 of Study RA0089

  Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)

• Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 24 of Study RA0089

  Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)

• Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 48 of Study RA0089

  Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)

• Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 96 of Study RA0089

  Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)

• The American College of Rheumatology (ACR) 20% (ACR20) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089

  Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)

Study Arms (1)

CDP6038 (olokizumab)

EXPERIMENTAL

CDP6038 (olokizumab) 120 mg: subcutaneous injections at q2w (every two weeks). RA0089 is a single arm study, however, analysis will be presented according to the original treatment arms of the parent study NCT01463059 (RA0083).

Biological: CDP6038 (olokizumab)

Interventions

CDP6038 (olokizumab) BIOLOGICAL

Biological/Vaccine: CDP6038 (olokizumab) 100 mg/mL solution for subcutaneous (sc) injection

CDP6038 (olokizumab)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 \[NCT01463059\]

Sponsors & Collaborators

• UCB BIOSCIENCES, Inc.: lead
• R-Pharm: collaborator

Study Sites (32)

102

Chiba, Japan

Location

114

Fukuoka, Japan

Location

115

Fukuoka, Japan

Location

113

Hiroshima, Japan

Location

120

Kakogawa, Japan

Location

118

Kumamoto, Japan

Location

116

Kurume, Japan

Location

122

Matsuyama, Japan

Location

107

Nagaoka, Japan

Location

110

Nagoya, Japan

Location

103

Narita, Japan

Location

112

Okayama, Japan

Location

119

Ōita, Japan

Location

100

Sapporo, Japan

Location

117

Sasebo, Japan

Location

123

Tokyo, Japan

Location

101

Tomakomai, Japan

Location

108

Tonami, Japan

Location

111

Tsu, Japan

Location

105

Yokohama, Japan

Location

104

Yotukaido, Japan

Location

200

Daejeon, South Korea

Location

201

Junggu, South Korea

Location

202

Seongdong-Gu, South Korea

Location

203

Seoul, South Korea

Location

204

Seoul, South Korea

Location

301

Taichung, Taiwan

Location

306

Taichung, Taiwan

Location

307

Taichung, Taiwan

Location

302

Taipei, Taiwan

Location

308

Taipei, Taiwan

Location

309

Taipei, Taiwan

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

olokizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

The clinical trial was terminated early following a strategic UCB decision to out-license the study drug for further development. No data were collected at Week 96 or beyond; no analysis was performed on study drug plasma levels or antibodies.

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001-844-599-2273

Study Officials

• Tsutomu Takeuchi, Professor

  Keio University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: RA0089 is a single arm study, however, analysis will also be performed according to the original treatment arms of the parent study NCT01463059 (RA0083).

Study Record Dates

• First Submitted: February 10, 2012
• First Posted: February 15, 2012
• Study Start: January 26, 2012
• Primary Completion: November 27, 2013
• Study Completion: November 29, 2013
• Last Updated: May 20, 2022
• Results First Posted: May 17, 2022

Record last verified: 2022-05

Locations

KR (5); JP (21); TW (6)