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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00152386




Registration number
NCT00152386
Ethics application status
Date submitted
7/09/2005
Date registered
9/09/2005
Date last updated
27/08/2014

Titles & IDs
Public title
A Placebo Controlled Study to Assess Efficacy and Safety of Certolizumab Pegol in the Treatment of Rheumatoid Arthritis
Scientific 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
Secondary ID [1] 0 0
2004-002993-49
Secondary ID [2] 0 0
C87027
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Certolizumab pegol (CDP870)

Treatment: Drugs: Certolizumab pegol (CDP870)


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Coffs Harbour
Recruitment hospital [3] 0 0
- Cotton Tree
Recruitment hospital [4] 0 0
- Malvern
Recruitment hospital [5] 0 0
- Shenton Park
Recruitment hospital [6] 0 0
- Victoria Park
Recruitment hospital [7] 0 0
- Westmead
Recruitment hospital [8] 0 0
- Wooloongabba
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Coffs Harbour
Recruitment postcode(s) [3] 0 0
- Cotton Tree
Recruitment postcode(s) [4] 0 0
- Malvern
Recruitment postcode(s) [5] 0 0
- Shenton Park
Recruitment postcode(s) [6] 0 0
- Victoria Park
Recruitment postcode(s) [7] 0 0
- Westmead
Recruitment postcode(s) [8] 0 0
- Wooloongabba
Recruitment outside Australia
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Alabama
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Arizona
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California
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Colorado
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Connecticut
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District of Columbia
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Idaho
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Missouri
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Nebraska
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Texas
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Argentina
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Capital Federal
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Argentina
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Cordoba
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Brussels
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Liege
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Pleven
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Sofia
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Stara Zagora
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Varna
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Courtice
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Hamilton
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Kitchener
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London
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Mississauga
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Montreal
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Newmarket
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Point Claire
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Sainte Foy
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Toronto
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Canada
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Winnipeg
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Chile
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Las Condes
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Chile
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Santiago Centro
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Chile
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Santiago
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Chile
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Temuco
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Croatia
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Rijeka
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Brno Bohunice
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Brno
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Ostrava Trebovice
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Prague 2
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Praha 5
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Praha
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Uherske Hradiste
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Zlin
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Ramat Gan
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Tel Aviv
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Latvia
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Riga
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Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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Ukraine
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Ivano-Frankivsk

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
UCB Pharma
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Patients will be assigned to one of three treatment groups. Study medication is administered
over a 52 week study duration.
Trial website
https://clinicaltrials.gov/show/NCT00152386
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Clinical Trial Call Center
Address 0 0
UCB Pharma
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications