A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050

• Register: EUCTR
• Last refreshed on: 3 April 2012
• Main ID: EUCTR2005-002629-30-CZ
• Date of registration: 01/02/2006
• Prospective Registration: Yes
• Primary sponsor: UCB Inc
• Public title: A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050
• Scientific title: A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050
• Date of first enrolment: 15/02/2006
• Target sample size: 450
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002629-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no 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

Countries of recruitment

Czech Republic, Estonia, Latvia, Lithuania

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patients must have either failed to achieve an ACR20 response at Week 12 (confirmed at Week 14) in the CDP870-050 trial or must have completed the entire CDP870-050 trial through Week 24.

2. Patients must have complied with the protocol requirements during their participation in trial CDP870-050.

3. Patients entering CDP870-051 who have completed the CDP870-050 trial must have a clear chest X-ray at the Entry visit (Week 24 Completion of CDP870-050). Patients who enter CDP870-051 at Week 16 of the CDP870-050 trial are not required to have a chest X-ray prior to enrollment.

4. Female patients of childbearing potential must have a negative urine pregnancy test at the Entry visit and must continue to have negative urine pregnancy tests administered immediately before every certolizumab pegol administration. Females must be either surgically sterile, be postmenopausal for at least 2 years prior
to screening visit, have undergone tubal ligation, or be using an acceptable method of birth control for the duration of the study and continuing for 12 weeks after the last dose of study drug (or longer if required by local regulations). Oral contraceptives must be stable for at least 28 days prior to Entry visit. Abstinence is not an acceptable method of contraception for the study.

5. Patients must continue treatment on methotrexate with or without folic acid throughout the study, unless given prior approval by UCB for discontinuation.

6. Patients must be able to understand the information provided to them and give written Informed Consent for CDP870-051.
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 Exclusion
1. Patients must not have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis).

2. Patients must not have a secondary condition (e.g. OA or fibromyalgia) that, in the Investigator’s opinion is symptomatic enough to interfere with evaluation of the effect of liquid certolizumab pegol on the patient’s primary diagnosis of RA.

3. Patients must not have a history of an infected joint prosthesis at any time if prosthesis still in situ.

Concomitant Medication Exclusion
4. At study entry patients must not be taking any of the prohibited medications as detailed in the CDP870-050 trial.

Medical History Exclusion
5. Female patients who are breast feeding, pregnant, or plan to become pregnant during the study and for 12 weeks following the last dose of study drug.

6. Patients with a history of chronic infection, recent serious or life-threatening infection during CDP870-050 participation (including herpes zoster), or any current (study entry assessment) sign or symptom that may indicate an infection.

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

8. Patients with a history of tuberculosis or positive chest X-ray for tuberculosis at the Entry visit.

9. Patients with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time.

10. Patients with a known positive hepatitis B surface antigen test and/or hepatitis C antibody test result.

11. Patients with known human immunodeficiency virus (HIV) infection.

12. Patients receiving any vaccination (live or attenuated) during the CDP870-050 trial with the exception of Influenza or Pneumococcal vaccines.

13. Patients with an active malignancy of any type or a history of malignancy (except basal cell carcinoma of the skin that has been excised prior to study start).

14. Patients with a history of blood dyscrasias.

15. Patients with a current or recent history, as determined by the investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient’s participation in the trial.

16. Patients with class III or IV congestive heart failure New York Heart Association (NYHA) 1964.

17. Patients with a history of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis).

18. Patients with a history of an adverse reaction to PEG or protein medicinal product.

19. Patients with any other condition (e.g., clinically significant abnormal laboratory values) 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: Certolizumab pegol
Product Code: CDP870
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Certolizumab pegol
Current Sponsor code: CDP870
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 200-

Primary Outcome(s)

Primary end point(s): Adverse Events
Extent of Exposure
Haematology
Biochemistry
Urinalysis
Urine pregnancy testing
Physical Examination
Vital signs
Body Mass
Concomitant Medication
Chest X-ray

Secondary Objective: 1. To continue to assess the tolerability of liquid certolizumab pegol every two weeks in patients with active RA.

2. To continue to assess the efficacy of liquid certolizumab pegol every two weeks in patients with active RA.

3. To continue to assess the effect of liquid certolizumab pegol every two weeks on physical function in patients with active RA.

4. To continue to assess the effect of liquid certolizumab pegol every two weeks on Health Outcome Measures in patients with active RA.

5. To continue to monitor the pharmacokinetic and immunogenicity profile of liquid certolizumab pegol every two weeks in patients with active RA.

Main Objective: To continue to assess the safety of the liquid formulation of certolizumab pegol, dosed at 400 mg sc every two weeks and 200 mg sc every two weeks, in treating signs and symptoms and preventing joint damage in patients with active rheumatoid arthritis (RA).

Secondary ID(s)

2005-002629-30-LT

CDP870-051