Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Interventions
Product Name: ACZ885
Product Code: ACZ885
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Canakinumab
Current Sponsor code: ACZ885
Other descriptive name: Recombinant human
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who completed the extension 1 study may enter the extension 2 study upon signing informed consent. A patient is defined as completing the extension 1 study if he/she completed the study up to and including Visit 31. 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
Exclusion criteria: Patients for whom continuation of treatment in the extension 2 is not considered appropriate by the treating physician. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation confirmed by a positive hCG laboratory test (>5mIU/mL). Women of childbearing potential (WOCBP) defined as all women physiologically capable of becoming pregnant, UNLESS they are: • Using a double barrier method of contraception such as intrauterine devices (IUDs), oral contraceptives, sub-dermal implants and a barrier method with spermicide, condoms. • Women whose partners have been sterilized by vasectomy or other means. • Considered post-menopausal and not of childbearing potential if they have had 24 months of natural (spontaneous) amenorrhea or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL (for US only estradiol < 20 pg/mL) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. Note: FSH and estradiol tests do not need to be performed for surgically sterile or women on estrogen replacement therapy. Females of childbearing potential must agree to continue to practice an acceptable form of birth control during the trial and for at least 2 months after completing the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess long-term safety and tolerability of canakinumab (ACZ885) in patients with active RA who completed the first extension study.;Primary end point(s): ;Secondary Objective: To evaluate the efficacy of canakinumab (ACZ885) by assessing the response to treatment according to ACR20, ACR50 and ACR70 criteria and DAS28. To assess the effect of canakinumab on ACR components, including a marker of inflammation (hsCRP). To assess pharmacokinetic profile of canakinumab. To assess immunogenicity of canakinumab. | — |
Countries
Austria, Germany, Spain
Outcome results
None listed