A Double-Blind, Randomised, Dose-Ranging Study to Compare K-832 with Placebo in the treatment of Patients with Active Rheumatoid Arthritis - N/A

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-000362-12-CZ
• Date of registration: 20/08/2004
• Prospective Registration: No
• Primary sponsor: Kowa Research Europe Ltd
• Public title: A Double-Blind, Randomised, Dose-Ranging Study to Compare K-832 with Placebo in the treatment of Patients with Active Rheumatoid Arthritis - N/A
• Scientific title: A Double-Blind, Randomised, Dose-Ranging Study to Compare K-832 with Placebo in the treatment of Patients with Active Rheumatoid Arthritis - N/A
• Date of first enrolment: 23/07/2004
• Target sample size: 260
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000362-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Czech Republic

Key inclusion & exclusion criteria

Inclusion criteria:
•Male or female aged between 18 and 75 years
•Diagnosed with RA for at least six months. Diagnosis is based on revised (1987) ACR Criteria for the Classification of RA (Appendix 2)
•Patients who have had active RA for at least six weeks. Patients who have six or more swollen and tender joints and who also have two out of three of the following:
a)morning stiffness lasting at least 45 minutes
b)ESR greater than 28 mm/h
c)CRP greater than 1.5 mg/dL
•Are in ACR functional class I, II or III (Appendix 3)
•Patients naïve to DMARDs or treatment experience with one or two DMARDs
•Females of childbearing potential must be using a highly reliable method of birth control (Pearl index <1.0) and must agree to continue using a highly reliable method of birth control throughout the study and for 30 days after the last intake of study medication. Medically acceptable highly reliable methods of contraception are:
a)an intrauterine device, or bilateral tubal ligation, or abstinence from intercourse, or partner vasectomised more than three months ago
b)a hormonal contraceptive method (implant, or depot injection, or oestrogen plus gestagen containing oral contraceptive) in combination with a barrier method (condom, or vaginal diaphragm, or cervical cap, or spermicide)
c)combination of two barrier methods (condom, spermicide, cervical cap, vaginal diaphragm [pessary])
• Are capable of giving informed consent to their participation in the study
•Are well-orientated, co-operative and able to communicate appropriately with their doctor.
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:
•Pregnancy or lactation (including a positive pregnancy test at screening [Visit 1])
•Females of childbearing potential who are not practising or not able to practise a highly reliable method of contraception or who do not agree to continue using a highly reliable method of contraception throughout the study and for 30 days after the last intake of study medication
•Patients who are not able to attend the clinic for regular study visits
•Patients who have experienced three or more DMARDs
•Patients who have received DMARDs in the four-week washout period
•Patients who have received doses of prednisolone exceeding 10 mg/day by i.m., i.v. and/or i.a. or equivalent corticosteroid in the four weeks prior to screening and patients who have been given similar steroidal oral drugs
•Patients who have at any time been treated with anti-cytokine biologics
•Patients who have a history of drug allergies
•Patients who have a serious infection history
•Patients who were found to have an abnormal chest X-ray examination, specific for active tuberculosis or other active infectious disease
•Therapy with any experimental treatment, including K-832, within the previous 90 days
•Peptic ulcer or history of active peptic ulcer during the four months directly preceding the screening visit
•Terminal illness
•Impaired renal function (serum creatinine > 160 µmol/l or > 1.8 mg/dl)
•Active liver disease, as shown by AST > 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) > 1.5 x ULN
•Known active viral hepatitis infection
•Congenital or known acquired immunodeficiency
•History of cancer or lymphoproliferative disease or treatment with total body irradiation (patients who have had a successfully treated basal cell carcinoma may be included)
•Patients who have donated and/or received any blood or blood products within the previous three months prior to screening.
•Any history of clinically significant drug abuse
•Any history of clinically significant alcohol abuse within the past three years
•Any other condition, which in the opinion of the investigator, would make the patient unsuitable or could interfere with the patient participating in and completing the study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis
MedDRA version: 6.0 Level: LLT Classification code 10028395

Intervention(s)

Product Name: K-832
Product Code: K-832
Pharmaceutical Form: Tablet
INN or Proposed INN: To be confirmed
CAS Number: 225666-85-3
Current Sponsor code: K-832
Other descriptive name: N/A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: K-832
Product Code: K-832
Pharmaceutical Form: Tablet
INN or Proposed INN: To be confirmed
CAS Number: 225666-85-3
Current Sponsor code: K-832
Other descriptive name: N/A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To evaluate the efficacy and safety of K-832 in patients with active rheumatoid arthritis.

Primary end point(s): The primary endpoint is the American College of Rheumatology (ACR) 20 composite endpoint at 16 weeks.

Secondary Objective:

Secondary ID(s)

N/A

K-832-2.01EU