A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis. - Realistic

• Register: EUCTR
• Last refreshed on: 8 October 2021
• Main ID: EUCTR2008-005427-28-FR
• Date of registration: 19/03/2009
• Prospective Registration: Yes
• Primary sponsor: UCB Pharma SA
• Public title: A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis. - Realistic
• Scientific title: A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis. - Realistic
• Date of first enrolment: 02/04/2009
• Target sample size: 1048
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005427-28
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: yes; Other trial design description: the second part of the trial design is open-label; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

France, Germany, Italy, Netherlands, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patients must be at least 18 years old at the screening visit.
2. Patients must be able to understand the information provided to them and to give written Informed Consent.
3. Female patients must be either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence only is not an acceptable method. Patients must agree to use adequate contraception during the study and for 12 weeks after their last dose of CZP. Male patients must agree to ensure they or their female partner(s) uses adequate contraception during the study and for 12 weeks after the patient receives their last dose of CZP.
4. Patients must have a diagnosis of adult–onset RA of at least three months duration as defined by the 1987 American College of Rheumatology classification criteria.
5. Patients must have active RA disease as defined by:
• =5 tender joints (28 joint count) at Screening and Baseline; and
• =4 swollen joints (28 joint count) at Screening and Baseline; and
• =10 mg/L CRP and/or =28mm/hour ESR (Westergren)
6. Patients must have had an unsatisfactory response or intolerance to at least one traditional DMARD
7. Patients must be able and willing to comply with the requirements of the study protocol.

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:
1. Patients have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis).
2. Patients have >3 arthroplasties due to RA and/or Steinbrocker IV functional capacity.
3. Patients have a secondary, non–inflammatory type of arthritis (e.g., osteoarthritis or fibromyalgia) that in the Investigator’s opinion is symptomatic enough to interfere with evaluation of the effect of study drug on the patient’s primary diagnosis of RA.
4. Patients have a history of an infected joint prosthesis at any time with that prosthesis still in situ.
5. Patients have received any of prohibited medication as detailed in the protocol.
6. Patients have received any experimental non–biological therapy, within or outside of a clinical study in the past three months or within 5 half-lives prior to Baseline visit (whichever is longer).
7. Patients have received any experimental biological agent within or outside of a clinical study in the past three months or within 5 half-lives prior to Baseline (whichever is longer).
8. Patients have received any biological therapy for RA within two months prior to Baseline visit, except for etanercept or anakinra for which a one month washout prior to baseline visit is acceptable.
9. Patients having discontinued or discontinuing biological therapy for their RA have had a severe hypersensitivity reaction or an anaphylactic reaction to more than 1 different biologic agent.
10. Patients have received treatment with more than 2 anti-TNF agents prior to enrollment in this study.
11. Patients have received treatment with rituximab and/or abatacept.
12. Female patients who are breast-feeding, pregnant, or plan to become pregnant during the study or within twelve weeks following last dose of study drug.
13. Patients with a history of chronic infection (more than 4 episodes requiring antibiotics/antivirals during the preceding year), recent serious or life–threatening infection within 6 months (including herpes zoster), or any current sign or symptom that may indicate an infection.
14. Patients with active TB (or history of active TB), positive chest X–ray for TB, or positive (defined as induration of = 5mm) PPD skin test or patients having close contact with an individual with active TB. Patients having a PPD skin test = 5 mm can enter the study, provided that active TB is excluded and provided that they are adequately treated for latent TB (e.g., isonicotinic acid hydrazide [INH therapy] for 9 months [with vitamin B6]) and provided that treatment is initiated at least 1 month prior to first administration of CZP.
15. Patients at a high risk of infection (e.g., leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections and patients who are permanently bedridden or wheelchair bound).
16. Patients with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease.
17. Patients with concurrent acute or chronic viral hepatitis B or C.
18. Patients with known human immunodeficiency virus (HIV) infection.
19. Patients receiving any vaccination (live or attenuated) within eight weeks prior to baseline (e.g., parenteral influenza and pneumococcal vaccines are allowed, but nasal influenza vaccine is not).
20. Concurrent malignancy or a history of malignancy (other than carcinoma of the cervix or basal cell carcinoma successfully treated more than five years prior to screening).
21. Patients with a current or rece

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

Health Condition(s) or Problem(s) studied

Rheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis

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: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): The primary efficacy variable is the ACR 20 (American College of Rheumatology 20% response criteria) responder rate at Week 12.

Safety variables to be assessed are adverse events, vital signs, physical examination (including symptoms of active tuberculosis), and measurements of laboratory parameters.

Clinical laboratory values (hematology, serum biochemistry, and urinalysis) will be collected and assessed.

Main Objective: To assess the clinical response rate as measured by American College of Rheumatology 20% (ACR20) response rate at Week 12.

Secondary Objective: • To assess:
- for all patients at Week 12, and every 8 weeks and at the completion/withdrawal visit in the group remaining in the study after Week 12:
- clinical response rate.
- reduction of disease activity.
- achievement of clinical remission.
- additionally, at Week 12:
- improvement in individual components of the ACR criteria
- Time to sustained ACR20 response.
- European League Against Rheumatism (EULAR) response.
- additionally, every 8 weeks and at completion/withdrawal visit :
- change from Baseline in individual components of the ACR criteria.

• Tolerability and safety of CZP therapy over the first 12 weeks of treatment and over the open-label treatment extension period.

• To evaluate the influence of some characteristics (as per protocol) on ACR20 response rate at Week 12 and adverse events rate with CZP therapy

Secondary ID(s)

C87094

2008-005427-28-NL

Ethics review

Status: Approved
Approval date: 02/04/2009
Contact:

Results

• Results available: Yes
• Date Posted: 25/12/2016
• Date Completed: 08/03/2011
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2008-005427-28/results