Rheumatoid Arthritis Clinical Trial
Official title:
An Open Label, Randomised Study to Compare the Efficacy of Certolizumab Pegol (CZP) Plus a Dynamic or Fixed Dose Treatment Strategy in Patients With Rheumatoid Arthritis, a Phase II Study
Tight control of an adaptive concomitant treatment strategy after initiation of CZP will lead to an improved outcome of RA patients with an active disease despite DMARD treatment.
Certolizumab pegol (CZP) is a tumor necrosis factor (TNF) antagonist which is marketed for
the treatment of moderate to severe rheumatoid arthritis (RA) (Keystone, 2008) when given in
combination with methotrexate (MTX). CZP is a PEGylated Fab' fragment of humanized anti-TNF
antibody with a high affinity for TNF.
RA is a chronic inflammatory autoimmune disease with multiple treatment strategies and
combination therapies available including analgesia, anti-inflammatory drugs and
disease-modifying anti-rheumatic drugs. Previous trials have demonstrated positive results
from the use of CZP but have compared its use to placebo in a fixed dose concomitant
medication regime rather than using a more realistic dynamic treatment strategy normally
employed in the clinical outpatient care of RA.
This trial is aimed at comparing the use of CZP in patients with moderate to severe RA when
administered in conjunction with an intensive, adapted treatment strategy (Group A) versus a
fixed-dosed program (Group B). CZP will be given in conjunction with MTX (a disease modifying
anti-arthritic drug - or DMARD), steroidal therapy in the form of prednisolone and joint
infiltrations of triamcinolone (another corticosteroid) and lidocaine (a pain therapy). Both
treatment arms will include these concomitant medications but there will be an intensive
adaptive approach adopted for the 'treat to target' population of Group A with a more
fixed-dose approach set-out for Group B. Patients will be centrally randomized after
screening to ensure a 50:50 ratio for both Groups in the study.
STUDY HYPOTHESIS
Tight control of an adaptive concomitant treatment strategy after initiation of CZP will lead
to an improved outcome of RA patients with an active disease despite DMARD treatment.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04226131 -
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
|
N/A | |
Completed |
NCT04171414 -
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT02833350 -
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
|
Phase 2 | |
Completed |
NCT04255134 -
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
|
Phase 4 | |
Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
Recruiting |
NCT06005220 -
SBD121, a Synbiotic Medical Food for RA Management
|
N/A | |
Recruiting |
NCT05451615 -
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT05054920 -
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT02037737 -
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
|
N/A | |
Recruiting |
NCT04079374 -
Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
|
Phase 3 | |
Completed |
NCT02504268 -
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
|
Phase 3 | |
Recruiting |
NCT05496855 -
Remote Care in People With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Recruiting |
NCT06103773 -
A Study of Single and Multiple Oral Doses of TollB-001
|
Phase 1 | |
Recruiting |
NCT06031415 -
Study of GS-0272 in Participants With Rheumatoid Arthritis
|
Phase 1 | |
Completed |
NCT05999266 -
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
|
||
Recruiting |
NCT05302934 -
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
|
||
Recruiting |
NCT04169100 -
Novel Form of Acquired Long QT Syndrome
|
Phase 4 |