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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	3 April 2012
Main ID:	EUCTR2005-001350-24-FI
Date of registration:	23/06/2005
Prospective Registration:	Yes
Primary sponsor:	UCB Inc.
Public title:	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027
Scientific title:	A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027
Date of first enrolment:	04/08/2005
Target sample size:	800
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001350-24
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
Phase:

Countries of recruitment
Czech Republic	Estonia	Finland	Hungary	Latvia	Lithuania

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
Patients must have either failed to achieve an ACR20 response at Weeks 12 and 14 in CDP870-027, or must have completed the entire Week 52 assessment of CDP870-027 trial.

Female patients must be either postmenopausal for at least one year, surgically incapable of child bearing, or effectively practicing an acceptable method of contraception (oral or parenteral hormonal contraceptives; intrauterine device; barrier and spermicide. Abstinence is not an acceptable method). Patients must agree to continue to use adequate contraception during the study and for 12 weeks after the last dose of study medication (or longer if required by local regulations).

Patients must have a clear chest X-ray at Entry visit.

Patients must be able to understand the information provided to them and to give written Informed Consent for CDP870-028.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
RA Disease Related:
1. A diagnosis of any other inflammatory arthritis e.g. psoriatic arthritis or ankylosing spondylitis.

2. 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.

3. A history of an infected joint prosthesis at any time with prosthesis still in situ.

4. Concomitant medication exclusion:
Any biological therapy.
Any experimental therapy, within or outside a clinical trial.

Medical History Exclusion
5. Lactating and/or pregnant female patients.

6. Female patients of child bearing are who are NOT practicing effective birth control (see Inclusion Criteria 2). All female patients must test negative on a urine pregnancy test before study entry and at each study visit

7. Serious or life-threatening infection (including herpes zoster), or any current sign or symptom that may indicate an infection (e.g. fever, cough).

8. Clinical or radiographic evidence of Tuberculosis (TB) at the Entry visit.

9. A history of chronic infection, recent serious or life-threatening infection (within six months, including herpes zoster), or a current sign or symptom that may indicate an infection (e.g. fever, cough).

10. Patients at a high risk of infection in the Investigator’s opinion (e.g. patients with leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections and patients who are permanently bedridden or wheelchair bound).

11. A known positive hepatitis B surface antigen test and/or hepatitis C antibody test result.

12. Known human immunodeficiency virus (HIV) infection.

13. Lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time.

14. A history of blood dyscrasias.

15. Active malignancy of any type.

16. Severe, progressive, and/or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease.

17. New York Heart Association (NYHA) class III-IV congestive heart failure.

18. Suspected or diagnosed demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis).

19. An adverse reaction to polyethylene glycol (PEG) or a protein medicinal product.

20. Any other condition, which in the Investigator’s judgment would make the patient unsuitable for inclusion in the study.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Rheumatoid arthritis
Classification code 10039073

Intervention(s)

Product Name: CDP870
Product Code: CDP870
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Certolizumab pegol
CAS Number: 428863-50-7
Current Sponsor code: CDP870
Other descriptive name: CDP870 Fab'-PEG
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 150 + or --15

Primary Outcome(s)

Primary end point(s): ACR 20 response

Main Objective: To continue to assess the safety of 400 mg CDP870 sc every two weeks and 200 mg CDP870 sc every two weeks in treating signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis (RA).

Secondary Objective: 1. To continue to assess the tolerability of CDP870 sc every two weeks in combination with methotrexate (MTX) in patients with active RA.

2. To continue to assess the efficacy of CDP870 sc every two weeks in combination with MTX in patients with active RA.

3. To continue to assess the effect of CDP870 sc every two weeks in combination with MTX on Physical Function in patients with active RA.

4. To continue to assess the effect of CDP870 sc every two weeks in combination with MTX on Health Outcome Measures in patients with active RA.

5. To continue to monitor the plasma concentration and immunogenicity profile of CDP870 sc every two weeks for the first two years of experience and then every six months between two and three years of experience in combination with MTX in patients with active RA.

Secondary Outcome(s)

Secondary ID(s)

CDP870-028

2005-001350-24-CZ

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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