An Open-label Extension Study of Certolizumab Pegol in Chinese Patients With Rheumatoid Arthritis Who Enrolled in RA0044

NCT02319642 | Completed Phase 3 Results DMC

• 2 other identifiers: RA0078CTR20140412
• Study Type: interventional
• Target: 347
• Locations: 1 country
• Sites: 30

Brief Summary

This study will continue to evaluate the safety \& efficacy of Certolizumab Pegol (CZP) for 6 months in Chinese subjects with active Rheumatoid Arthritis who participated in RA0044.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; TNFα antagonist; Certolizumab pegol; Chinese patients; Open-label

Outcome Measures

Primary Outcomes (3)

• Percentage of Subjects That Withdrew Due to a Treatment-emergent Adverse Event (TEAE)

  TEAEs are defined as Advere Events (AEs) starting on or after the date of first study medication administration in this Open-label Extension (OLE) study up to 70 days post-last dose.

  Baseline to the end of observation period (32 weeks)

• Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)

  TEAEs are defined as Adverse Events (AEs) starting on or after the date of first study medication administration in this Open-label Extension (OLE) study up to 70 days post-last dose.

  Baseline to the end of observation period (32 weeks)

• Percentage of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE)

  Treatment emergent SAEs are defined as SAEs starting on or after the date of first study medication administration in this OLE study up to 70 days post-last dose.

  Baseline to the end of observation period (32 weeks)

Secondary Outcomes (4)

• Percentage of Subjects Meeting the American College of Rheumatology 20 (ACR20) in Relation to Baseline

  Week 24

• Percentage of Subjects Meeting the American College of Rheumatology 50 (ACR50) in Relation to Baseline

  Week 24

• Percentage of Subjects Meeting the American College of Rheumatology 70 (ACR70) in Relation to Baseline

  Week 24

• Change From Baseline Value in Health Assessment Questionnaire-Disability Index (HAQ-DI)

  Week 24

Study Arms (1)

Certolizumab Pegol (CZP)

EXPERIMENTAL

1. Those subjects from either treatment group in RA0044 (NCT02151851) who fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14. These subjects are withdrawn from RA0044 (NCT02151851) at Week 16 of that study, and that assessment will also be the Entry assessment for this Extension study. In this OLE study, these subjects will receive CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W. 2. Subjects from either treatment group in RA0044 (NCT02151851) who completed RA0044 (NCT02151851) through Week 24. The Week 24 assessment in RA0044 (NCT02151851) will also be the Entry assessment for this Extension study. In this OLE study, these subjects will receive CZP 200 mg sc Q2W.

Drug: Certolizumab Pegol

Interventions

Certolizumab Pegol DRUG

Active Substance: Certolizumab Pegol Pharmaceutical form: Prefilled syringes Concentration: 200 mg/ ml Route of Administration: Subcutaneous injection

Also known as: Cimzia

Certolizumab Pegol (CZP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An Institutional Review Board (IRB)/ Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) for RA0078 is signed and dated by the subject or by the parent(s) or legal representative
• Subject/ legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator
• Subjects must either have:
• Completed RA0044 through Week 24, OR
• Failed to achieve an ACR20 response at Week 12 (confirmed at Week 14) in RA0044
• Subjects must have complied with the protocol requirements during their participation in RA0044
• Subjects entering RA0078 who have completed RA0044 must have a clear chest x-ray at the Week 24 Completion Visit of RA0044. Subjects who enter RA0078 at Week 16 of the RA0044 study are not required to have a chest x-ray prior to enrollment
• Subject is able to continue treatment with Methotrexate (MTX) (with or without folic acid) at a dose deemed appropriate by the Investigator
• Female subjects with childbearing potential should have a negative pregnancy test at Entry and should have a medically accepted method of contraception used during the entire duration of the study and for 10 weeks after the last dose of Certolizumab pegol (CZP). Medically accepted methods of contraception are: hormonal contraception for at least 2 cycles prior to Screening, intrauterine device, implant device, diaphragm with spermicide, bilateral tubal ligation, monogamous relationship with vasectomized (for at least 3 months prior to Screening) partner, or using condoms with spermicide gel. Abstinence is not an acceptable method of contraception for the study. Female subjects who are postmenopause for at least 2 years or had undergone a complete hysterectomy, bilateral tubal ligation and/ or bilateral ovariectomy, or have a congenital sterility are considered not of childbearing potential. Male subjects must agree to ensure they use adequate contraception during the study and for at least 10 weeks after the subject receives their last dose of study medication

You may not qualify if:

• Subjects have a diagnosis of any other inflammatory arthritis eg, psoriatic arthritis or ankylosing spondylitis
• Subjects have a secondary, noninflammatory type of arthritis (eg, osteoarthritis or fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of CZP on the subject's primary diagnosis of RA
• Subjects have a history of an infected joint prosthesis at any time with that prosthesis still in situ
• Subjects must be free of the following concomitant medications:
• Any biological therapy for RA
• Any experimental therapy, within or outside a clinical trial (except RA0044)
• Lactating and/or pregnant female subjects
• Male subjects with childbearing potential partner(s) and female subjects of childbearing potential who are NOT practicing effective birth control. All female subjects must test negative on a urine pregnancy test before study entry and at each study visit
• Subjects with known TB infection, at high risk of acquiring TB infection, or latent TB (LTB) infection (with exception) are excluded
• Subjects who had 3 or more infections requiring systemic antibiotics during RA0044
• Subjects with a history of chronic infection, recent serious or life-threatening infection (within 6 months, including herpes zoster), or a current sign or symptom that may indicate an infection (eg, fever, cough)
• Subjects with a history or active systemic/ respiratory infection due to fungal, parasitic, or mycotic pathogens including but not limited to histoplasmosis, coccidiosis, paracoccidiosis, pneumocystis, blastomyces, aspergillus, and nontuberculous mycobacteria (NTMB)
• Subjects at a high risk of infection in the Investigator's opinion (eg, subjects with leg ulcers, indwelling urinary catheter, and persistent or recurrent chest infections, and subjects who are permanently bedridden or wheelchair bound)
• Subjects with a known positive hepatitis B surface antigen (HBsAg) test and/ or hepatitis C virus antibody (anti-HCV) test result
• Subjects with known human immunodeficiency virus (HIV) infection

Sponsors & Collaborators

• UCB Pharma SA: lead
• Parexel: collaborator

Study Sites (30)

037

Baotou, China

Location

001

Beijing, China

Location

002

Beijing, China

Location

013

Beijing, China

Location

021

Beijing, China

Location

025

Beijing, China

Location

033

Beijing, China

Location

014

Bengbu, China

Location

034

Changchun, China

Location

017

Changsha, China

Location

019

Changsha, China

Location

007

Chengdu, China

Location

012

Chengdu, China

Location

004

Guangzhou, China

Location

015

Hangzhou, China

Location

005

Hefei, China

Location

008

Heilongjiang, China

Location

011

Jilin, China

Location

022

Jinan, China

Location

031

Kunming, China

Location

028

Nanjing, China

Location

009

Shanghai, China

Location

018

Shanghai, China

Location

020

Shanghai, China

Location

030

Shanghai, China

Location

038

Shijiazhuang, China

Location

010

Tianjin, China

Location

006

Wuhan, China

Location

016

Xi'an, China

Location

035

Xi'an, China

Location

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

+1844 599

Study Officials

• UCB Cares

  +1 887.822.9493

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: December 18, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 16, 2018
• Results First Posted: October 16, 2018

Record last verified: 2018-10

Locations

CN (30)