A randomized, double-blind, double-dummy, active-controlled, parallel group study of single doses of ACZ885 in hospitalized patients with acute gout - Not available
- Conditions
- Acute goutMedDRA version: 9.1Level: LLTClassification code 10018628Term: Gout acute
- Registration Number
- EUCTR2007-003037-17-GB
- Lead Sponsor
- ovartis Pharma Services
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 44
1. Male or female subjects aged 18 to 80 years (inclusive).
2. Female subjects of childbearing potential must use two acceptable methods of contraception. Postmenopausal females must have had no regular menstrual bleeding for at least one (1) year prior to initial dosing. Menopause will be confirmed by a plasma FSH level of >40 IU/L at screening Female subjects who report surgical sterilization must have had the procedure at least six (6) months prior to initial dosing. Periodic adstinence (e.g. calender, ovulation, symptom-termal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
3. Male subjects must use two acceptable methods of contraception , (e.g., spermicidal gel plus condom) for the entire duration of the study, up to the Study Completion visit, and refrain from fathering a child in the six (6) months following study completion. Periodic adstinence and withdrawal are not accpetable methods of contraception.
4. Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 to 35 kg/m2. See Appendix 3 of this protocol for BMI ranges.
5, Patients must score over 40 on the 0-100 VAS pain scale.
6. Patients must be willing to undergo diagnostic arthrocentesis and must have MSU crystals documented by joint aspiration and subsequent microscopy to confirm acute gout if there is no record of a previous aspiration. A repeat aspiration is not required if a history of MSU crystals by microscopic exam documented in the medical record is present. The crystals may have been identified in any joint or from a tophus. Crystals observed in a urinalysis are not acceptable, since this may be a normal finding.
7. Presence of acute gout flare for no longer than 4 days at screening.
8. Able to return to the hospital or Investigator-affiliated clinic for outpatient follow up assessments.
9. Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
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
1. Smokers whose smoking habits interfere with the conduct of the study.
2. Use of any TNF inhibitor within the past 3 months.
3. Use of any concomitant medication for the treatment of acute gout within the previous 24 hours prior to screening other than a dose of < 10 mg prednisone or the equivalent or no more than 1 single dose of 0.6 mg colchicine (unless this treatment was judged by the Investigator as ineffective). Low dose aspirin (=325mg once daily) low dose ibuprofen (=600mg daily), naproxen (=500mg daily), or dose of any other NSAID or COX-2 inhibitor judged comparable by the investigator, as well as use of chronic, hypouricaemic therapy (e.g. allopurinol, probenrcid) are not exclusion criteria. Concommitant chronic, hypouricaemic therapy (e.g. allopurinol, probenecid, sulfinpyazone or benzbromarone), may initiated during treatment period at the discretion of teh clinical investigator.
4. Class 4 Heart Failure (baseline compensated status prior to hospital admission).
5. Hepatic cirrhosis associated with a prolonged PT.
6. Life expectancy less than 1 year.
7. Participation in any clinical trial for an investigational drug within four weeks prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
8. Donation or loss of 400ml or more of blood within eight weeks prior to initial dosing, or longer if required by local regulation.
9. Clinical suspicion of an active infection.
10. Pregnant or breastfeeding women.
11. Major surgery with high infection risk (including total joint arthroplasty, open heart, gastrointestinal, diabetes-related surgery) within 1 month of the dose.
12.History of clinically significant atopy (e.g. steroid dependent asthma and urticaria) and /or allergies to the therapeutic /compound class being used in this study.
13. History of immunodeficiency diseases, including a previous, positive HIV (ELISA and Western blot) test result.
14. Known presence of viral hepatitis infection. History or risk (according to the MMWR 2000 guidance) of tuberculosis.
15. History or risk (according to the MMWR 2000 guidance) of tuberculosis.
16. Presence of severe renal function impairment (< 30 mL/min estimated creatinine clearance). History of renal trauma, glomerulonephritis, patients with one kidney, or renal failure requiring regular dialysis treatments.
17. History of malignancy (other than non-melanoma skin carcinoma or adequately treated carcinoma-in-situ of the cervix or prostate carcinoma which has not required treatment)
18. Systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg
19. Uncontrolled diabetes (screening blood glucose > 300 mg/dl)
20. History of drug or alcohol abuse which in the opinion of the investigator places a participating patient at increased risk and/or interferes with the conduct of the study.
21. Presence or history of underlying metabolic, endocrine, hematologic, pulmonary, cardiac, blood, renal, hepatic, infectious, psychiatric or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and/or places the patient at unacceptable risk for the participation in a study of an immunomodulatory therapy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method