A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy - LX3305.201
- Conditions
- Rheumatoid Arthritis (RA)MedDRA version: 12.0Level: LLTClassification code 10039073Term: <Manually entered code. Term in E.1.1>
- Registration Number
- EUCTR2009-012705-19-HU
- Lead Sponsor
- exicon Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 104
Subjects must meet all of the following criteria at screening to be considered eligible for participation in the study:
1. Adult subjects, aged >18 years and <75 years
2. Both males and females of childbearing potential must agree to practice two adequate methods of contraception from the screening visit through the end of the follow-up period. Childbearing potential is defined as those who have not undergone surgical sterilization, or those who are not considered post-menopausal (absence of menstruation for at least 2 years). Adequate methods of contraception for subjects and their partners include condoms with spermicidal gel, diaphragm with spermicidal gel, coil (intrauterine device), surgical sterilization, vasectomy, oral contraceptive pill or depoprogesterone injections, and abstinence. If a subject is not usually sexually active but becomes active, the subject and his or her partner should use medically accepted forms of contraception.
3. Active RA diagnosed at least 6 months prior to screening, functional class I to III RA (as defined by the 1987 ACR criteria)
4. Continued active disease as determined by the presence of:
a. A minimum of 6 swollen joints (at screening and Day 1) AND
b. A minimum of 6 tender joints (at screening and Day 1) AND
c. Serum C-reactive protein (CRP) level > ULN
5. Treated with MTX for at least 6 months (7.5 to 25 mg/week) prior to screening, and currently receiving a stable dose of MTX (>10 mg/week) and with a stable route of administration, as well as folate supplementation. Both MTX and folate supplementation must be stable for at least 8 weeks prior to Day 1, and they should remain stable throughout study participation.
6. If taking NSAIDs, steroids, minocycline, or doxycycline, must be on stable regimen for 6 weeks prior to Day 1 (oral steroid dose must be =10 mg prednisone per day, or equivalent)
7. If taking hydroxychloroquine or sulfasalazine, must be on a stable regimen for 12 weeks prior to Day 1
8. Ability to give 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
Subjects who meet any of the following criteria at screening will be excluded from participation in the study:
1. Women who are pregnant or nursing
2. RA diagnosis prior to 16 years of age (Juvenile RA)
3. Subjects who have demonstrated lack of response to >3 DMARDs, or subjects who have been exposed to >1 biologic DMARD
4. Use of DMARDs, other than MTX and those defined in the Inclusion Criteria, within 12 weeks prior to Day 1
5. Use of leflunomide within 4 weeks, or use of biologic DMARDs within 12 weeks, prior to Day 1, with the exception of rituximab or other B-cell depleting therapies, which cannot be used within 12 months prior to Day 1
6. Intra-articular and/or parenteral corticosteroids within 4 weeks prior to Day 1
7. Receipt of live vaccine within 4 weeks prior to Day 1
8. Major surgical procedure within 8 weeks prior to Day 1
9. Blood donation within 4 weeks prior to Day 1
10. Any systemic inflammatory condition that may interfere with the interpretation of outcome data
11. Recurrent infections, or presence of current infection within 2 weeks prior to Day 1, other than onychomycosis
12. History of bleeding diathesis
13. History of medically significant opportunistic infection
14. History of drug or alcohol abuse within 3 years prior to Day 1
15. History of cancer within 5 years prior to Day 1, other than resected basal cell carcinoma
16. Presence of hepatic or biliary disease, including symptomatic cholelithiasis
17. History of tuberculosis
18.Positive result for purified protein derivative (PPD) skin test, defined as >5 mm of induration. If a subject exhibits a positive PPD test, but prior immunization with Bacille Calmette Guerin (BCG) vaccine can be ascertained, a repeat test withQuantiferon-TB, in conjunction with a normal chest X-ray taken within 6 months prior to screening, may be used to establish eligibility
19. History of human immunodeficiency virus (HIV)
20. Abnormal laboratory results meeting the following criteria:
a. Hemoglobin <10.0 gm/dL
b. Absolute lymphocyte count <750/mm3
c. Platelet count <100,000/µL
d. Aspartate transaminase (AST) or alanine transaminase (ALT) >1.5 x ULN
e. Alkaline phosphatase (ALP) >1.5 x ULN
f. Presence of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb)
g. Microscopic hematuria
21. Any other clinically significant laboratory test results, ECG, X-ray, medical condition, or unspecified reason that, in the opinion of the investigator, make the subject unsuitable for enrollment
22. Previous exposure to LX3305
23. Use of any other investigational agent or participation in an investigational trial within 30 days prior to Day 1, or use of an investigational biologic agent within 90 days, or less than five half-lives, prior to Day 1
24. Inability to communicate or cooperate with the investigator for any reason, or inability to attend visits as outlined in the protocol.
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