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Clinical Trials/EUCTR2011-001342-15-DE
EUCTR2011-001342-15-DEActive, not recruitingNot Applicable

A 36-week open-label extension study of CACZ885H2361 on the safety and tolerability of canakinumab 150 mg s.c. pre-filled syringe (PFS) in treating acute gouty arthritis flares in frequently flaring patients - H2361E1

ovartis Services AG0 sites360 target enrollmentStarted: October 25, 2011Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
360
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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.

Investigators

Sponsor
ovartis Services AG

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