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

Purpose

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

Condition	Intervention	Phase
Rheumatoid Arthritis	Biological: Placebo Biological: Olokizumab 60 mg Biological: Olokizumab 120 mg Biological: Olokizumab 240 mg	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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.

Enrollment:	119
Study Start Date:	October 2011
Study Completion Date:	February 2013
Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo every 2 weeks Injections administered at week 0, 2, 4, 6, 8 and 10	Biological: Placebo Placebo solution for injection, administered as subcutaneous injections
Experimental: Olokizumab 60 mg every 2 weeks Olokizumab 60 mg injections administered at week 0, 2, 4, 6, 8 and 10	Biological: Olokizumab 60 mg Olokizumab 60 mg solution for injection, administered as subcutaneous injections Other Name: CDP6038
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	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
Experimental: Olokizumab 120 mg every 2 weeks Olokizumab 120 mg injections administered at week 0, 2, 4, 6, 8 and 10	Biological: Olokizumab 120 mg Olokizumab 120 mg solution for injection, administered as subcutaneous injections Other Name: CDP6038
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	Biological: Placebo Placebo solution for injection, administered as subcutaneous injections Biological: Olokizumab 120 mg Olokizumab 120 mg solution for injection, administered as subcutaneous injections Other Name: CDP6038
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	Biological: Placebo Placebo solution for injection, administered as subcutaneous injections Biological: Olokizumab 240 mg Olokizumab 240 mg solution for injection, administered as subcutaneous injections Other Name: CDP6038

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463059

Locations

Japan
102
Chiba, Japan
114
Fukuoka, Japan
115
Fukuoka, Japan
113
Hiroshima, Japan
120
Kakogawa, Japan
118
Kumamoto, Japan
116
Kurume, Japan
121
Matsuyama, Japan
122
Matsuyama, Japan
107
Nagaoka, Japan
110
Nagoya, Japan
103
Narita, Japan
119
Oita, Japan
112
Okayama, Japan
100
Sapporo, Japan
117
Sasebo, Japan
124
Tokorozawa, Japan
123
Tokyo, Japan
101
Tomakomai, Japan
108
Tonami, Japan
111
Tsu, Japan
105
Yokohama, Japan
104
Yotukaido, Japan
Korea, Republic of
200
Daejeon, Korea, Republic of
201
Jung-gu, Korea, Republic of
202
Seongdong-gu, Korea, Republic of
203
Seoul, Korea, Republic of
204
Seoul, Korea, Republic of
Taiwan
303
Changhua, Taiwan
304
Dalin-Town, Taiwan
305
Hualien, Taiwan
300
Kaohsiung, Taiwan
306
Taichung, Taiwan
301
Taichung, Taiwan
307
Taichung, Taiwan
309
Taipei, Taiwan
302
Taipei, Taiwan
308
Taipei, Taiwan
310
Taipei, Taiwan

Sponsors and Collaborators

UCB Japan Co. Ltd.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB, Inc. ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier:	NCT01463059 History of Changes
Other Study ID Numbers:	RA0083
Study First Received:	October 27, 2011
Last Updated:	March 19, 2013
Health Authority:	Japan: Ministry of Health, Labor and Welfare South Korea: Korea Food and Drug Administration (KFDA) Taiwan : Food and Drug Administration

Keywords provided by UCB, Inc.:

Rheumatoid Arthritis
Monoclonal Antibody
Interleukin-6
Olokizumab
CDP6038

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases

Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013