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Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier:
NCT01463059
First received: October 27, 2011
Last updated: March 19, 2013
Last verified: March 2013

October 27, 2011
March 19, 2013
October 2011
February 2013   (final data collection date for primary outcome measure)
Change from Baseline in the Disease Activity Score 28-joint count (C-reactive protein) (DAS28[CRP]) at Week 12 [ Time Frame: From Week 0 (Baseline) to Week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01463059 on ClinicalTrials.gov Archive Site
  • Number of responders in American College of Rheumatology 20% Response Criteria (ACR20) at Week 12 [ Time Frame: From Week 0 (Baseline) to Week 12 ] [ Designated as safety issue: No ]
    Number of subjects who achieve ACR 20 will be calculated at week 12. 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 12 [ Time Frame: From Week 0 (Baseline) to Week 12 ] [ Designated as safety issue: No ]
    Number of subjects who achieve ACR 50 will be calculated at week 12. 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 12 [ Time Frame: From Week 0 (Baseline) to Week 12 ] [ Designated as safety issue: No ]
    Number of subjects who achieve ACR 70 will be calculated at week 12. The calculations 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.
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) Therapy
A Randomized, Double-blind, Placebo Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Asian Subjects With Active Rheumatoid Arthritis Having Previously Failed TNF Blocker Therapy

The primary objective of this study is to evaluate the efficacy and safety of CDP6038 administered subcutaneous (sc) at various doses compared to placebo.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Biological: Placebo
    Placebo solution for injection, administered as subcutaneous injections
  • Biological: Olokizumab 60 mg
    Olokizumab 60 mg solution for injection, administered as subcutaneous injections
    Other Name: CDP6038
  • Biological: Olokizumab 120 mg
    Olokizumab 120 mg solution for injection, administered as subcutaneous injections
    Other Name: CDP6038
  • Biological: Olokizumab 240 mg
    Olokizumab 240 mg solution for injection, administered as subcutaneous injections
    Other Name: CDP6038
  • Placebo Comparator: Placebo every 2 weeks
    Injections administered at week 0, 2, 4, 6, 8 and 10
    Intervention: Biological: Placebo
  • Experimental: Olokizumab 60 mg every 2 weeks
    Olokizumab 60 mg injections administered at week 0, 2, 4, 6, 8 and 10
    Intervention: Biological: Olokizumab 60 mg
  • Experimental: Olokizumab 60 mg every 4 weeks
    Olokizumab 60 mg injection administered at week 0, 4, and 8 and Placebo injection administered at week 2, 6, and 10
    Interventions:
    • Biological: Placebo
    • Biological: Olokizumab 60 mg
  • Experimental: Olokizumab 120 mg every 2 weeks
    Olokizumab 120 mg injections administered at week 0, 2, 4, 6, 8 and 10
    Intervention: Biological: Olokizumab 120 mg
  • Experimental: Olokizumab 120 mg every 4 weeks
    Olokizumab 120 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10
    Interventions:
    • Biological: Placebo
    • Biological: Olokizumab 120 mg
  • Experimental: Olokizumab 240 mg very 4 weeks
    Olokizumab 240 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10
    Interventions:
    • Biological: Placebo
    • Biological: Olokizumab 240 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have a diagnosis of adult-onset RA of at least 6 months' (24 weeks) duration as defined by the 1987 ACR classification criteria or a score of ≥6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for RA
  • Must have moderately to severely active RA disease as defined by ≥6 tender joints (68-joint count) at Screening and Baseline, ≥6 swollen joints (66-joint count) at Screening and Baseline, CRP ≥1.2 times the upper limit of normal (ULN) or ESR >28mm/hour
  • Must be on an MTX dose of 6 to 16mg/week in Japan or 7.5 to 20mg/week in Korea and Taiwan, which has been stable for at least 6 weeks prior to Screening with a stable route of administration
  • Must have had intolerance or inadequate response to treatment with 1 or more TNF-blocker therapies within 2 years of Screening
  • 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 a diagnosis of any other inflammatory arthritis
  • Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the study or within 24 weeks
  • Disease modifying antirheumatic drug (DMARDs) other than methotrexate (MTX)
  • Subjects with known concurrent acute or chronic viral hepatitis B or C infection
  • Subject has known tuberculosis (TB) disease, high risk of acquiring TB infection, or latent TB infection
  • Subjects with known history of or current clinically active infection
  • Subjects at high risk of infection
  • Subjects with known human immunodeficiency virus (HIV) or human T cell lymphotropic virus type 1 (HTLV 1) infection
  • Have received vaccinations within 8 weeks prior to Screening or plan to receive vaccines during the study (with the exception of injectable influenza and pneumococcal vaccinations which are permitted)
  • Concurrent malignancy or a history of malignancy (with the exception of successfully treated carcinoma of the cervix more than 5 years prior to Screening or no more than 2 successfully treated basal cell carcinomas within 2 years prior to Screening
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan,   Korea, Republic of,   Taiwan
 
NCT01463059
RA0083
No
UCB Pharma ( UCB Japan Co. Ltd. )
UCB Japan Co. Ltd.
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
March 2013

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