ong-term safety and tolerability of Canakinumab Prefilled Syringes in frequently flaring acute gouty arthritis patients

• Conditions: Evaluate the long-term safety, tolerability and immunogenicity of canakinumab 150 mg s.c. administered as pre-filled syringe (PFS).; MedDRA version: 14.0Level: LLTClassification code 10018628Term: Gout acuteSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-001342-15-DE
• Lead Sponsor: ovartis Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-25
• Last Update Posted: 9 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

- Signed written informed consent before any study procedure is performed.
- Completion of the core study CACZ885H2361 up to and including the End of Study visit (Visit 8) having fulfilled the entry criteria, completed the study and with acceptable compliance (no protocol deviations).
- Patients remain with unchanged significant clinical medical history from entry to completion of the core study CACZ885H2361.
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

- If entering in this extension study would be considered inappropriate 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 pregnancy test (serum or urine).
- Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partner has been sterilized by vasectomy or other means. Women are
considered post menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor
symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal
litigation 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 is she considered not of child
bearing potential, unless they are using effective methods of contraception during dosing of study treatment. Effective contraception methods include:
a. Use of oral, injected or implanted hormonal methods of contraception
b. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
c. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
d. Total abstinence or male/female sterilization

- No additional exclusions may be applied by the investigator, in order to ensure that the study
population will be representative of all eligible patients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified