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Open-label Study to Assess the Safety and Efficacy of CDP6038 (Olokizumab) in Patients Who Completed RA0056

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01296711
Recruitment Status : Terminated (Decision to out-license the compound for further development)
First Posted : February 15, 2011
Results First Posted : April 14, 2022
Last Update Posted : April 14, 2022
Sponsor:
Collaborator:
R-Pharm
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Tracking Information
First Submitted Date  ICMJE February 14, 2011
First Posted Date  ICMJE February 15, 2011
Results First Submitted Date  ICMJE January 27, 2017
Results First Posted Date  ICMJE April 14, 2022
Last Update Posted Date April 14, 2022
Actual Study Start Date  ICMJE March 7, 2011
Actual Primary Completion Date May 1, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2022)
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days) ]
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
Original Primary Outcome Measures  ICMJE
 (submitted: February 14, 2011)
The occurrence of any adverse event. [ Time Frame: From baseline through end of study (up to 5 years) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2022)
  • Change From Baseline (Week 0 of Study RA0056) in the Disease Activity Score-28-joint Count (C-reactive Protein) (DAS28[CRP]) to Week 12 of Study RA0057 [ Time Frame: Baseline (Week 0 of Study RA0056) and Week 12 (Study RA0057) ]
    DAS28(CRP) was calculated using the tender/painful joint count (TJC) and swollen joint count (SJC) from 28 joints, the Patient's Global Assessment of Disease Activity (PtGADA)-Visual Analog Scale (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 the 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 the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
  • Change From Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 24 of Study RA0057 [ Time Frame: Baseline (Week 0 of Study RA0056) and Week 24 (Study RA0057) ]
    DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP 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 the 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 the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
  • Change From Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 48 of Study RA0057 [ Time Frame: Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057) ]
    DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP 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 the 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 the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
  • Change From Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 96 of Study RA0057 [ Time Frame: Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057) ]
    DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP 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 the 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 the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
  • The American College of Rheumatology (ACR) 20% (ACR20) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057 [ Time Frame: Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057) ]
    ACR20 represents at least 20% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: 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), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
  • The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057 [ Time Frame: Baseline (Week 0 of Study RA0056) up to Week 24 (Study RA0057) ]
    ACR20 represents at least 20% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: 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), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
  • The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057 [ Time Frame: Baseline (Week 0 of Study RA0056) up to Week 48 (Study RA0057) ]
    ACR20 represents at least 20% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: 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), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
  • The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057 [ Time Frame: Baseline (Week 0 of Study RA0056) up to Week 96 (Study RA0057) ]
    ACR20 represents at least 20% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: 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), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
  • The ACR 50% (ACR50) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057 [ Time Frame: Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057) ]
    ACR50 represents at least 50% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: 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), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
  • The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057 [ Time Frame: Baseline (Week 0 of Study RA0056) up to Week 24 (Study RA0057) ]
    ACR50 represents at least 50% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: 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), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
  • The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057 [ Time Frame: Baseline (Week 0 of Study RA0056) up to Week 48 (Study RA0057) ]
    ACR50 represents at least 50% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: 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), its 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.
  • The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057 [ Time Frame: Baseline (Week 0 of Study RA0056) up to Week 96 (Study RA0057) ]
    ACR50 represents at least 50% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: 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), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
  • The ACR 70% (ACR70) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057 [ Time Frame: Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057) ]
    ACR70 represents at least 70% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: 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), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
  • The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057 [ Time Frame: Baseline (Week 0 of Study RA0056) up to Week 24 (Study RA0057) ]
    ACR70 represents at least 70% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: 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), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
  • The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057 [ Time Frame: Baseline (Week 0 of Study RA0056) up to Week 48 (Study RA0057) ]
    ACR70 represents at least 70% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: 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), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
  • The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057 [ Time Frame: Baseline (Week 0 of Study RA0056) up to Week 96 (Study RA0057) ]
    ACR70 represents at least 70% improvement from Baseline for each of TJC (68 joints) + SJC (66 joints) + at least 3 components of 5 for: 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), its score (0-3) computed from item scores, with lower scores indicates less disability. • CRP in mg/L. Missing values were considered as non-responding status.
  • Percentage of Subjects With DAS28(CRP) <2.6 at Week 12 of Study RA0057 [ Time Frame: Week 12 (Study RA0057) ]
    DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP 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 the 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 the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than 2.6 implies remission.
  • Percentage of Subjects With DAS28(CRP) <2.6 at Week 24 of Study RA0057 [ Time Frame: Week 24 (Study RA0057) ]
    DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP 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 the 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 the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than 2.6 implies remission.
  • Percentage of Subjects With DAS28(CRP) <2.6 at Week 48 of Study RA0057 [ Time Frame: Week 48 (Study RA0057) ]
    DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP 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 the 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 the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than 2.6 implies remission.
  • Percentage of Subjects With DAS28(CRP) <2.6 at Week 96 of Study RA0057 [ Time Frame: Week 96 (Study RA0057) ]
    DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP 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 the 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 the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than 2.6 implies remission.
  • Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 12 of Study RA0057 [ Time Frame: Week 12 (Study RA0057) ]
    DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP 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 the 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 the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than or equal to (<=) 3.2 implies low disease activity.
  • Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 24 of Study RA0057 [ Time Frame: Week 24 (Study RA0057) ]
    DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP 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 the 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 the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score <=3.2 implies low disease activity.
  • Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 48 of Study RA0057 [ Time Frame: Week 48 (Study RA0057) ]
    DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP 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 the 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 the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score <=3.2 implies low disease activity.
  • Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 96 of Study RA0057 [ Time Frame: Week 96 (Study RA0057) ]
    DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP 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 the 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 the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score <=3.2 implies low disease activity.
  • Change From Baseline (Week 0 of Study RA0056) in the Clinical Disease Activity Index (CDAI) to Week 48 of Study RA0057 [ Time Frame: Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057) ]
    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; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (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.
  • Change From Baseline (Week 0 of Study RA0056) in the CDAI to Week 96 of Study RA0057 [ Time Frame: Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057) ]
    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; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (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.
  • Change From Baseline (Week 0 of Study RA0056) in the Simplified Disease Activity Index (SDAI) to Week 48 of Study RA0057 [ Time Frame: Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057) ]
    SDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS, PhGADA-VAS and CRP (in milligrams per decilitre [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; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (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.
  • Change From Baseline (Week 0 of Study RA0056) in the SDAI to Week 96 of Study RA0057 [ Time Frame: Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057) ]
    SDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS, PhGADA-VAS and CRP (in milligrams per decilitre [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; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2011)
  • Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] [ Time Frame: From baseline of the prior study (RA0056) to Week 12 ]
  • Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] [ Time Frame: From baseline of the prior study (RA0056) to Week 24 ]
  • Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] [ Time Frame: From baseline of the prior study (RA0056) to Week 48 ]
  • Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] [ Time Frame: From baseline of the prior study (RA0056) to Week 96 ]
  • American College of Rheumatology 20 (ACR20) response status [ Time Frame: From baseline of the prior study (RA0056) to Week 24 ]
  • American College of Rheumatology 20 (ACR20) response status [ Time Frame: From baseline of the prior study (RA0056) to Week 48 ]
  • American College of Rheumatology 50 (ACR50) response status [ Time Frame: From baseline of the prior study (RA0056) to Week 96 ]
  • American College of Rheumatology 70 (ACR70) response status [ Time Frame: From baseline of the prior study (RA0056) to Weeks 24, 48, and 96 ]
  • DAS28(CRP) <2.6 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 12 ]
  • DAS28(CRP) <2.6 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 24 ]
  • DAS28(CRP) <2.6 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 48 ]
  • DAS28(CRP) <2.6 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 96 ]
  • DAS28(CRP) <3.2 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 12 ]
  • DAS28(CRP) <3.2 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 24 ]
  • DAS28(CRP) <3.2 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 48 ]
  • DAS28(CRP) <3.2 response status [ Time Frame: From baseline Baseline of the prior study (RA0056) to Week 96 ]
  • Change from Baseline in the Clinical Disease Activity Index (CDAI) [ Time Frame: From baseline of the prior study (RA0056) to Week 48 ]
  • Change from Baseline in the Clinical Disease Activity Index (CDAI) [ Time Frame: From baseline of the prior study (RA0056) to Week 96 ]
  • Change from Baseline in the Simplified Disease Activity Index (SDAI) [ Time Frame: From baseline of the prior study (RA0056) to Week 48 ]
  • Change from Baseline in the Simplified Disease Activity Index (SDAI) [ Time Frame: From baseline of the prior study (RA0056) to Week 96 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-label Study to Assess the Safety and Efficacy of CDP6038 (Olokizumab) in Patients Who Completed RA0056
Official Title  ICMJE A Phase 2, Multicenter, Open-Label, Follow-up Study to Assess the Long-Term Safety and Efficacy of CDP6038 (Olokizumab) Administered Subcutaneously to Subjects With Active Rheumatoid Arthritis Who Completed Study RA0056
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 who completed study RA0056 (NCT01242488).
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 two weeks, for the treatment of active rheumatoid arthritis.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
RA0057 is a single arm study, however, analyses will also be performed according to the original treatment arms of the parent study RA0056 (NCT01242488).
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Biological: CDP6038 (olokizumab)
100mg/ml solution for injection 120 mg subcutaneously (sc) every 2 weeks
Study Arms  ICMJE Experimental: CDP6038 (olokizumab)
Intervention: Biological: CDP6038 (olokizumab)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 14, 2011)
190
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 5, 2013
Actual Primary Completion Date May 1, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject completed the RA0056 study (Week 12 Visit)
  • Subject must have maintained their stable dose (and route) of methotrexate (MTX) between 12.5 to 25mg/week in RA0056, 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 an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence is not considered an acceptable method of contraception for this study
  • Female subjects of childbearing potential must agree to use 2 methods of adequate contraception during the study and for 6 months (24 weeks) after their last CDP6038 (olokizumab) dose
  • Male subjects must agree to ensure that they or their female partner(s) use adequate contraception during the study and for 12 weeks after the subject receives their last dose of CDP6038 (olokizumab)

Exclusion Criteria:

  • Subject has an ongoing serious adverse event from the RA0056 study
  • Female subject of childbearing potential has a positive pregnancy test at Week 12 in Study RA0056 or plans to become pregnant during the study or within 6 months (24 weeks) following their last dose of study medication
  • Subject has evidence of active or latent tuberculosis
  • Subject is receiving any biologic response modifier or synthetic disease-modifying antirheumatic drug other than MTX
  • Subject has an alcohol consumption of more than 1 unit per weekday. One unit equals 1 glass of beer or lager (~330mL), a glass of wine (125mL), or a measure of spirits/hard liquor (25mL)
  • Subject with any other condition in RA0056 (eg, clinically significant laboratory values, frequent adverse events) which in the Investigator's or Sponsor's judgment would make the subject unsuitable for inclusion in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01296711
Other Study ID Numbers  ICMJE RA0057
2010-022224-77 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party UCB Pharma ( UCB BIOSCIENCES, Inc. )
Original Responsible Party Study Director, UCB
Current Study Sponsor  ICMJE UCB BIOSCIENCES, Inc.
Original Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE R-Pharm
Investigators  ICMJE
Principal Investigator: Mark Genovese, Dr Stanford University
PRS Account UCB Pharma
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP