A Study of Certolizumab Pegol as Additional Therapy in Chinese Patients With Active Rheumatoid Arthritis

NCT02151851 | Completed Phase 3 Results DMC

• 1 other identifier: RA0044
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 30

Brief Summary

This study will evaluate the safety \& efficacy of Certolizumab Pegol (CZP) as additional medication to Methotrexate (MTX) in Chinese subjects with Rheumatoid Arthritis. 400 patients will be randomized to receive either CZP + MTX or placebo + MTX. Anticipated time in the study is about 32 weeks.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; TNFα antagonist; Certolizumab Pegol; Chinese patients

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 24

  The assessments are based on a 20 % or greater improvement from Baseline to Week 24 in the number of tender joints, in the number of swollen joints, and a 20 % or greater improvement in at least 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).

  Week 24

Secondary Outcomes (3)

• Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 24

  Week 24

• Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 24

  Week 24

• Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24

  Baseline, Week 24

Study Arms (2)

Certolizumab Pegol + Methotrexate

EXPERIMENTAL

Subjects will receive loading doses of CZP 400 mg (200 mg / prefilled syringe \[PFS\], ie, 2 injections) at Baseline, and Weeks 2 and 4; then CZP 200 mg (1 injection) Q2W until Week 22. All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week).

Biological: Certolizumab Pegol; Drug: Methotrexate

Placebo + Methotrexate

PLACEBO COMPARATOR

Subjects will receive Placebo (1mL / prefilled syringe \[PFS\], ie, 2 injections) at Baseline, and Weeks 2 and 4; then Placebo (1 injection) Q2W until Week 22. All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week).

Drug: Methotrexate; Other: Placebo

Interventions

Certolizumab Pegol BIOLOGICAL

* Active substance: Certolizumab Pegol * Pharmaceutical Form: Prefilled syringes * Concentration: 200 mg/ml * Route of administration: Subcutaneous injection

Also known as: Cimzia

Certolizumab Pegol + Methotrexate

Methotrexate DRUG

* Active substance: Methotrexate * Pharmaceutical form: Tablet * Concentration: Maximum dose 10 mg per week * Route of administration: Oral

Certolizumab Pegol + Methotrexate; Placebo + Methotrexate

Placebo OTHER

* Active substance: Placebo * Pharmaceutical form: Prefilled syringes * Concentration: 0.9 % saline * Route of Administration: Subcutaneous injection

Placebo + Methotrexate

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) is signed and dated by the subject or by the legal representative
• Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgment of the Investigator
• Subject is male or female, and at least 18 years of age at the Screening Visit
• Subjects must have a diagnosis of adult onset Rheumatoid Arthritis RA of at least 6 months duration as defined by the 1987 American College of Rheumatology (ACR) classification criteria (Arnett et al, 1988).
• Subjects must have active RA disease as defined by:
• ≥6 tender joints at Screening and Baseline
• ≥6 swollen joints at Screening and Baseline
• Fulfilling 1 of the following 2 criteria during the Screening Period:
• European League Against Rheumatism (ESR) (Westergren) ≥30 mm/hour, or
• C-reactive protein (CRP) \>15 mg/L
• Subjects must have a normal chest x ray within 3 months prior to the Baseline Visit
• Female subjects with childbearing potential should have a negative pregnancy test at Screening and at Baseline 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).
• 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
• Subjects must have received treatment with Methotrexate (MTX) (with or without folic acid) for at least 3 months prior to the Baseline Visit. The dose and route of administration of MTX must have been stable for at least 2 months prior to the Baseline Visit. The minimum stable dose of MTX allowed is 10 mg weekly

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 study medication on the subject's primary diagnosis of Rheumatoid Arthritis (RA)
• Subjects have a history of an infected joint prosthesis at any time with that prosthesis still in situ
• Subjects have \>3 arthroplasties due to RA and/or Steinbrocker IV functional capacity
• Subjects have previously participated in this study or subject has previously been assigned to treatment in a study of the medication under investigation in this study
• Subjects have participated in another study of an investigational medicinal product (or a medical device) within the previous 3 months or are currently participating in another study of an investigational medicinal product (or a medical device)
• Subjects have received any experimental nonbiological therapy, within or outside a clinical study in the 3 months or within 5 half lives (whichever is longer) prior to Baseline Visit
• Subjects have received any biological therapy for RA within 3 months or within 5 half lives (whichever is longer) prior to Baseline Visit, except for Etanercept and Anakinra where only a 1 month washout prior to the Baseline Visit is necessary
• Subjects have received Rituximab or Tocilizumab
• Subjects have received Yunke (technetium-99 conjugated with methylene diphosphonate) other than for diagnostic purpose within 5 years prior to Baseline
• Subjects have received previous treatment with a biological therapy for RA that resulted in a severe hypersensitivity reaction or an anaphylactic reaction
• Subjects who failed to respond to previous treatment with a Tumor Necrosis Factor (TNF) blocking drug are excluded. Subjects who initially responded to a maximum of 2 TNF blocking agents but who later discontinued the agent(s) due to loss of efficacy or other reasons may be included
• Female subjects who are breast feeding, pregnant, or plan to become pregnant during the study or for 3 months following last dose of study medication
• 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)

Sponsors & Collaborators

• UCB Pharma SA, Belgium: 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

011

Changchun, 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

008

Harbin, China

Location

005

Hefei, 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; Methotrexate

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; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

+1844 599

Study Officials

• UCB Cares

  UCB Pharma

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: May 30, 2014
• Study Start: July 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 28, 2018
• Results First Posted: March 20, 2018

Record last verified: 2018-04

Locations

CN (30)