A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA). - Tranilast plus Methotrexate vs MTX Alone in Patients with Active RA

• Conditions: Patients with active rheumatoid arthritis who are on a stable dose of methotrexate

• Registration Number: EUCTR2008-006917-25-GB
• Lead Sponsor: uon Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1.Signed and dated written Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved informed consent obtained from the subject in accordance with the local regulations;
2.Male or female subjects, =18 to =75 years of age, who have a diagnosis of RA (using the American Rheumatism Association 1987 Revised Criteria) for at least 6 months prior to screening, and are Functional Class 1-3 (as defined by the 1991 Revised Criteria for the Classification of Global Functional Status in Rheumatoid Arthritis) at baseline;
3.Subjects must be receiving MTX (oral or parenteral) at a dose of at least 10 mg/week for =6 months and at a stable dose and route of administration for =8 weeks prior to randomization (Day 0);
4.Subjects must receive at least 5 mg of folic acid or folinic acid per week at a stable dose for at least 4 weeks prior to randomization (Day 0);
5.Subjects must have at least 8 painful/tender and 6 swollen joints (based upon 68/66 joint counts) at screening and baseline (Day 0);
6.Subjects must have an elevated CRP level (defined as > the upper limit of normal [ULN] for the central lab) or an elevated ESR (defined as > the upper limit of normal [ULN] for the local lab) at screening;
7.Availability of normal chest X-ray within the last 6 months (i.e., no evidence of TB or chest infection). Patients who are clinically asymptomatic with minor changes consistent with rheumatoid lung are acceptable.
8.Subjects may be receiving:
•Oral steroids at a stable dose of <=10 mg/day of prednisone (or equivalent corticosteroid dose) if previously taken for at least one month prior to randomization (Day 0);
•Chronic NSAIDs if taken at a stable dose for at least one month prior to randomization (occasional use of NSAIDs for relief of headaches menstrual cramps, and minor pain unrelated to RA is allowed);
•Hydroxychloroquine if taken at a stable dose of 200-400 mg PO daily or chloroquine if taken at a stable dose of up to 250 mg PO daily for at least 3 months prior to randomization, with no evidence of ocular toxicity as documented by ophthalmologic exam within the previous 12 months;
•Sulfasalazine if taken at a stable daily dose of up to 3000 mg for at least 3 months prior to randomization;
9.Females of childbearing potential must agree to continue to use adequate contraception (i.e., hormonal [oral, depot, patch], IUD, or barrier and spermicide) throughout the study and for at least 1 month following their last study visit;
10.In the opinion of the investigator, the subject will be compliant and have a high probability of completing the study and all required procedures.

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

1.Use of intra-articular corticosteroid injections within one month prior to randomization (Day 0);
2.Use of other anti-arthritic treatments not mentioned in the above inclusion criteria, including approved or experimental oral, topical, or injectable biologics or drugs, or devices within 3 months or 5 half-lives (whichever is longer)prior to randomization (Day 0);
3.Pregnant or nursing females;
4.Subjects who have received prior treatment with tranilast;
5.Subjects who have any known hypersensitivity to any of the excipients contained in the study drug formulation;
6.Use of any of the following other medications: (a) oral hypoglycemic agents: tolbutamide, glipizide, glimepiride, glyburide, repaglinide, nateglinide, or a thiazolidenedione (glitazones”, e.g. rosiglitazone); (b) warfarin or coumarol; (c) phenytoin, paclitaxel, fluconazole, amiodarone, or isoniazid; (d) a uricosuric agent for gout; or (e) an investigational medication or participation in an investigational study within 3 months of Day 0
7.Subjects with any laboratory test at screening considered significantly abnormal. The following will be considered significantly abnormal:
•alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase >=1.25 times the upper limit of normal (ULN) or
•cytopenia (to include any of the following: WBC <3.5x10cubed/µL; Hgb <10 g/dL; platelets <100x10cubed/µL; neutrophils absolute <1.5x10cubed/µL; lymphocytes absolute <0.8x10cubed/µL) or
•Creatinine >=1.25 times the upper limit of normal (ULN)
8.Has an elevated total bilirubin (e.g., outside the upper limit of normal), which persists upon repeat or a history of Gilbert’s syndrome;
9.History of clinically significant renal or hepatic dysfunction or disease;
10.Has a history of or has a current, clinically significant major psychiatric disorder
(e.g., major depressive disorder, psychosis, schizophrenia) according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV TR) [Exception; subjects with depression that has been adequately controlled for at least 6 months may enroll in the study];
11.Has a history of alcohol or drug dependence or abuse as defined by DSM IV TR criteria within the last 2 years;
12.Has a history of uric acid urolithiasis or gout;
13.Has a clinically significant systemic infection (e.g., chronic or acute infection, UTI, URI) within 30 days of Day 0, or a history or presence of recurrent or chronic infection
(e.g., viral infections, including hepatitis B or C, HIV), bacterial infections, systemic fungal infections, or syphilis);
14.Has evidence of tuberculosis as indicated by subjects with a positive tuberculin (TB) skin test at screening or within the 30 days prior to screening (defined as >=10 mm induration);
15.Has any other significant medical disease, mental impairment or other clinically significant abnormality on physical, neurological, laboratory, vital signs or ECG examination that the investigator or Sponsor believes would be detrimental to the subject or compromise the study;
16.Subject with any other condition, clinical finding, or reason that, in the opinion of the investigator and/or Sponsor, is determined to be unsuitable for enrollment into the study (e.g., subject with known compliance issues, geographical constraints for attending required clinic visits);
17.Presence of, or history of cancer with the exception of completely excised, non-metastatic squamous cell

Study & Design

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