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

UCB

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Biological: Olokizumab 120 mg; Biological: Placebo; Biological: Olokizumab 60 mg; Biological: Olokizumab 240 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01463059

RA0083

Details and patient eligibility

About

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

Enrollment: 119 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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119 participants in 6 patient groups, including a placebo group

Placebo every 2 weeks

Placebo Comparator group

Description:

Injections administered at week 0, 2, 4, 6, 8 and 10

Treatment:

Biological: Placebo

Olokizumab 60 mg every 2 weeks

Experimental group

Description:

Olokizumab 60 mg injections administered at week 0, 2, 4, 6, 8 and 10

Treatment:

Biological: Olokizumab 60 mg

Olokizumab 60 mg every 4 weeks

Experimental group

Description:

Olokizumab 60 mg injection administered at week 0, 4, and 8 and Placebo injection administered at week 2, 6, and 10

Treatment:

Biological: Olokizumab 60 mg

Biological: Placebo

Olokizumab 120 mg every 2 weeks

Experimental group

Description:

Olokizumab 120 mg injections administered at week 0, 2, 4, 6, 8 and 10

Treatment:

Biological: Olokizumab 120 mg

Olokizumab 120 mg every 4 weeks

Experimental group

Description:

Olokizumab 120 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10

Treatment:

Biological: Placebo

Biological: Olokizumab 120 mg

Olokizumab 240 mg very 4 weeks

Experimental group

Description:

Olokizumab 240 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10

Treatment:

Biological: Olokizumab 240 mg

Biological: Placebo