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.

INTERVENTION:

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

CONDITION:

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

PRIMARY OUTCOME:

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

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.

Epistemonikos ID.: be81942d08f5653635354a5d50afb57c9a6302c2


First added on: Mar 24, 2022