Efficacy and Safety of Olokizumab With Rheumatoid Arthrit... | NCT01463059

Status Module

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo every 2 weeks	Placebo Comparator	Injections administered at week 0, 2, 4, 6, 8 and 10	Biological: Placebo
Olokizumab 60 mg every 2 weeks	Experimental	Olokizumab 60 mg injections administered at week 0, 2, 4, 6, 8 and 10	Biological: Olokizumab 60 mg
Olokizumab 60 mg every 4 weeks	Experimental	Olokizumab 60 mg injection administered at week 0, 4, and 8 and Placebo injection administered at week 2, 6, and 10	Biological: Placebo Biological: Olokizumab 60 mg
Olokizumab 120 mg every 2 weeks	Experimental	Olokizumab 120 mg injections administered at week 0, 2, 4, 6, 8 and 10	Biological: Olokizumab 120 mg
Olokizumab 120 mg every 4 weeks	Experimental	Olokizumab 120 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10	Biological: Placebo Biological: Olokizumab 120 mg
Olokizumab 240 mg very 4 weeks

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Biological	Placebo solution for injection, administered as subcutaneous injections	Olokizumab 120 mg every 4 weeks Olokizumab 240 mg very 4 weeks

Outcomes Module

Measure	Description	Time Frame
Change from Baseline in the Disease Activity Score 28-joint count (C-reactive protein) (DAS28[CRP]) at Week 12		From Week 0 (Baseline) to Week 12

Secondary Outcomes

Measure	Description	Time Frame
Number of responders in American College of Rheumatology 20% Response Criteria (ACR20) at Week 12	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.

Eligibility Module

Eligibility Criteria

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

Name	Affiliation	Role
UCB Clinical Trial Call Center	+1 877 822 9493 (UCB)	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26358841	Derived	Takeuchi T, Tanaka Y, Yamanaka H, Amano K, Nagamine R, Park W, Shiozawa K, Tsukano M, Wei JC, Shao J, Togo O, Mashimo H. Efficacy and safety of olokizumab in Asian patients with moderate-to-severe rheumatoid arthritis, previously exposed to anti-TNF therapy: Results from a randomized phase II trial. Mod Rheumatol. 2016;26(1):15-23. doi: 10.3109/14397595.2015.1074648. Epub 2015 Sep 10.

Facility	Status	City	State	ZIP	Country	Contacts
102		Chiba			Japan
114

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases