A Placebo Controlled Study to Assess Efficacy and Safety of Certolizumab Pegol in the Treatment of Rheumatoid Arthritis - Full Text View

Purpose

Patients will be assigned to one of three treatment groups. Study medication is administered over a 52 week study duration.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Certolizumab pegol (CDP870)	Phase III

MedlinePlus related topics:

Rheumatoid Arthritis

ChemIDplus related topics:

Methotrexate Certolizumab pegol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment

Official Title:	A Phase III Multicentre, Double Blind, Placebo-Controlled, Parallel Group 52-Week Study to Assess the Efficacy and Safety of 2 Dose Regimens of Lyophilised CDP870 as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate

Further study details as provided by UCB:

Primary Outcome Measures:

To assess the efficacy of CDP870 in combination with Methotrexate in the treatment of Rheumatoid Arthritis and prevention of structural damage by measuring the ACR20 response at week 24 and change from Baseline

Secondary Outcome Measures:

Change from Baseline in mTSS at week 24, Change from Baseline in HAQ-DI at weeks 24 and 52, ACR20 responder rate at week 52, ACR50 and ACR70 responder rate at weeks 24 and 52

Estimated Enrollment:	950
Study Start Date:	February 2005
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Male and female, aged at least 18 years old at the Screening visit.
A clear chest X-ray within 3 months prior to Baseline visit.
A diagnosis of adult-onset RA (of at least six months duration but not longer than 15 years prior to Screening) as defined by the 1987 American College of Rheumatology classification criteria.
Active RA disease at Screening and Baseline as defined by:
- ≥9 tender joints.
- ≥9 swollen joints. and fulfilling 1 of the following 2 criteria:
- ≥30 mm/hour ESR (Westergren), or
- CRP >15 mg/L.
Must have received a stable dose of MTX with or without folic acid for at least 3 months prior to Baseline visit. The minimum dose is 10 mg MTX weekly.
Patient must be willing to attend for a Week 52 X-ray of the hands and feet even if they are no longer receiving study treatment but have not withdrawn their informed consent.

Exclusion Criteria:

A diagnosis of any other inflammatory arthritis e.g., psoriatic arthritis or ankylosing spondylitis.
A secondary, non-inflammatory type of arthritis (e.g. OA or fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of CDP870 on the patient's primary diagnosis of RA.
A history of an infected joint prosthesis at any time with prosthesis still in situ.
Does not meet exclusionary concomitant medication criteria.
A history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time.
Patients at a high risk of infection in the Investigator's opinion (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152386

Sponsors and Collaborators

UCB

Investigators


Study Director:	Jeff White, MD	UCB

More Information

Study ID Numbers:	C87027
First Received:	September 7, 2005
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00152386
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Directorate general for the protection of Public health: Medicines; Bulgaria: Bulgarian Drug Agency; Canada: Health Canada; Chile: Instituto de Salud Publica de Chile; Croatia: Ministry of Health and Social Care; Czech Republic: State Institute for Drug Control; Estonia: The State Agency of Medicine; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut; Hungary: National Institute of Pharmacy; Israel: Israeli Health Ministry Pharmaceutical Administration; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health; Mexico: Federal Commission for Protection Against Health Risks; Netherlands: Medicines Evaluation Board (MEB); New Zealand: Food Safety Authority; Russia: Pharmacological Committee, Ministry of Health; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Slovakia: State Institute for Drug Control; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Ukraine: State Pharmacological Center - Ministry of Health; United States: Food and Drug Administration