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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463059
• Other study ID #: RA0083
• Status: Completed
• Phase: Phase 2
• First received: October 27, 2011
• Last updated: March 19, 2013
• Start date: October 2011
• Est. completion date: February 2013

Study information

• Verified date: March 2013
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareSouth Korea: Korea Food and Drug Administration (KFDA)Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• Placebo
Placebo solution for injection, administered as subcutaneous injections
• Olokizumab 60 mg
Olokizumab 60 mg solution for injection, administered as subcutaneous injections
• Olokizumab 120 mg
Olokizumab 120 mg solution for injection, administered as subcutaneous injections
• Olokizumab 240 mg
Olokizumab 240 mg solution for injection, administered as subcutaneous injections

Locations

Country	Name	City	State
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
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
Taiwan	303	Changhua
Taiwan	304	Dalin-Town
Taiwan	305	Hualien
Taiwan	300	Kaohsiung
Taiwan	301	Taichung
Taiwan	306	Taichung
Taiwan	307	Taichung
Taiwan	302	Taipei
Taiwan	308	Taipei
Taiwan	309	Taipei
Taiwan	310	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
UCB Japan Co. Ltd.

Countries where clinical trial is conducted

Japan,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	From Week 0 (Baseline) to Week 12	No
Secondary	Number of responders in American College of Rheumatology 50% Response Criteria (ACR50) at Week 12	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.	From Week 0 (Baseline) to Week 12	No
Secondary	Number of responders in American College of Rheumatology 70% Response Criteria (ACR70) at Week 12	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.	From Week 0 (Baseline) to Week 12	No