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

Multi-center, Open-label, Follow-up Study to Assess the Long-term Safety and Efficacy of CDP6038 (Olokizumab) Administered Subcutaneously to Asian Subjects With Active Rheumatoid Arthritis Who Completed Study RA0083

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].

Study Overview

• Status: Terminated
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Biological: CDP6038 (olokizumab)

Detailed Description

Male and female subjects were randomized in a multi-center, open-label, follow-up study to assess the long-term safety and efficacy of a subcutaneous dose of 120 mg CDP6038 (olokizumab), every 2 weeks (q2w), for the treatment of active RA.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Chiba, Japan
    • 102
  • Fukuoka, Japan
    • 114
  • Fukuoka, Japan
    • 115
  • Hiroshima, Japan
    • 113
  • Kakogawa, Japan
    • 120
  • Kumamoto, Japan
    • 118
  • Kurume, Japan
    • 116
  • Matsuyama, Japan
    • 122
  • Nagaoka, Japan
    • 107
  • Nagoya, Japan
    • 110
  • Narita, Japan
    • 103
  • Oita, Japan
    • 119
  • Okayama, Japan
    • 112
  • Sapporo, Japan
    • 100
  • Sasebo, Japan
    • 117
  • Tokyo, Japan
    • 123
  • Tomakomai, Japan
    • 101
  • Tonami, Japan
    • 108
  • Tsu, Japan
    • 111
  • Yokohama, Japan
    • 105
  • Yotukaido, Japan
    • 104
• Korea, Republic of
  • Daejeon, Korea, Republic of
    • 200
  • Jung-Gu, Korea, Republic of
    • 201
  • Seongdong-Gu, Korea, Republic of
    • 202
  • Seoul, Korea, Republic of
    • 203
  • Seoul, Korea, Republic of
    • 204
• Taiwan
  • Taichung, Taiwan
    • 301
  • Taichung, Taiwan
    • 306
  • Taichung, Taiwan
    • 307
  • Taipei, Taiwan
    • 302
  • Taipei, Taiwan
    • 308
  • Taipei, Taiwan
    • 309

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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]

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CDP6038 (olokizumab); 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); Biological/Vaccine: CDP6038 (olokizumab) 100 mg/mL solution for subcutaneous (sc) injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	DAS28(CRP) was calculated using tender/painful joint count (TJC) and swollen joint count (SJC) from 28 joints, Patient's Global Assessment of Disease Activity (PtGADA)-Visual Analog Scale (VAS), and CRP as per formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: •TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. 28 joints included shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores greater than (>) 5.1 correspond with active disease, scores less than (<) 3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity.	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	DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity.	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	DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity.	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	DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity. Since the study was terminated early before Week 96, no results data are available for analysis at the Week 96 time point and this Outcome Measure has zero total participants analyzed.	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	ACR20 represents at least 20% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, Physician's Global Assessment of Disease Activity (PhGADA)-VAS, Patient's Assessment of Arthritis Pain (PAAP)-VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI) and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.	Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089	ACR20 represents at least 20% improvement from Baseline in TJC (68 joints) + SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.	Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089	ACR20 represents at least 20% improvement from Baseline in TJC (68 joints) + SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.	Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089	ACR20: at least 20% improvement from Baseline in TJC (68 joints) + SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.	Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
The ACR 50% (ACR50) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089	ACR50 represents at least 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.	Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089	ACR50 represents at least 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.	Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089	ACR50 represents at least 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.	Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089	ACR50:atleast 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.	Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
The ACR 70% (ACR70) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089	ACR70 represents at least 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.	Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089	ACR70 represents at least 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.	Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089	ACR70 represents at least 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.	Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089	ACR70:atleast 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.	Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
Percentage of Subjects With DAS28(CRP) <2.6 at Week 12 of Study RA0089	DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) <2.6 were reported.	Week 12 (Study RA0089)
Percentage of Subjects With DAS28(CRP) <2.6 at Week 24 of Study RA0089	DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) <2.6 were reported.	Week 24 (Study RA0089)
Percentage of Subjects With DAS28(CRP) <2.6 at Week 48 of Study RA0089	DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) <2.6 were reported.	Week 48 (Study RA0089)
Percentage of Subjects With DAS28(CRP) <2.6 at Week 96 of Study RA0089	DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) <2.6 were reported. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.	Week 96 (Study RA0089)
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 12 of Study RA0089	DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) less than or equal to (≤) 3.2 were reported.	Week 12 (Study RA0089)
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 24 of Study RA0089	DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) ≤3.2 were reported.	Week 24 (Study RA0089)
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 48 of Study RA0089	DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) ≤3.2 were reported.	Week 48 (Study RA0089)
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 96 of Study RA0089	DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores >5.1 correspond with active disease, scores <3.2 correspond with well controlled disease, and scores <2.6 correspond with remission or similar. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.	Week 96 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) in the Clinical Disease Activity Index (CDAI) at Week 48 of Study RA0089	CDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS and PhGADA-VAS, according to the following formula: SJC + TJC + PtGADA + PhGADA Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). The 28 joints included the shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of the hands; and the knees. Total score range is from 0-100, with the high scores representing high disease activity. A negative change in CDAI score indicates an improvement in disease activity.	Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) CDAI at Week 96 of Study RA0089	CDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS and PhGADA-VAS, according to the following formula: SJC + TJC + PtGADA + PhGADA Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). The 28 joints included the shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of the hands; and the knees. Total score range is from 0-100, with the high scores representing high disease activity. A negative change in CDAI score indicates an improvement in disease activity. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.	Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) in the Simplified Disease Activity Index (SDAI) at Week 48 of Study RA0089	SDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS, PhGADA-VAS and CRP (mg/dL]), according to the following formula: SJC + TJC + PtGADA + PhGADA + CRP (mg/dL) Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). • CRP range was from 0 to 10 mg/dL. The 28 joints included the shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of the hands; and the knees. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. A negative change in SDAI score indicates an improvement in disease activity.	Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
Change From Baseline (Week 0 of Study RA0083) in the SDAI at Week 96 of Study RA0089	SDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS, PhGADA-VAS and CRP (mg/dL]), as per formula: SJC + TJC + PtGADA + PhGADA + CRP (mg/dL) Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). • CRP range was from 0 to 10 mg/dL. The 28 joints included the shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of the hands; and the knees. SDAI score ranges from 0 to 86, with higher scores representing worse disease. A negative change in SDAI score indicates an improvement in disease activity. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.	Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
Plasma Concentration of CDP6038 (Olokizumab) at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120	The CDP6038 (olokizumab) plasma levels data were not collected and analyzed. This Outcome Measure therefore has zero total participants analyzed.	Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120
Plasma Concentration of Anti-CDP6038 (Olokizumab) Antibodies at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96 and 120	The CDP6038 (olokizumab) plasma levels data were not collected and analyzed. This Outcome Measure therefore has zero total participants analyzed.	Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120

Collaborators and Investigators

• Sponsor: UCB BIOSCIENCES, Inc.
• Collaborators: R-Pharm
• Investigators: Principal Investigator: Tsutomu Takeuchi, Professor, Keio University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 26, 2012
• Primary Completion (ACTUAL): November 27, 2013
• Study Completion (ACTUAL): November 29, 2013

Study Registration Dates

• First Submitted: February 10, 2012
• First Submitted That Met QC Criteria: February 10, 2012
• First Posted (ESTIMATE): February 15, 2012

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Monoclonal antibody; Rheumatoid Arthritis; Interleukin-6; Olokizumab; CDP6038
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: RA0089