A Double-Blind, Parallel, Randomized Extension Trial to Evaluate Safety and Efficacy of TMI-005 (Apratastat) in Subjects with Rheumatoid Arthritis on Methotrexate Who Have Completed Protocol 3140A1-200-WW
- Conditions
- Rheumatoid Arthritis
- Registration Number
- EUCTR2004-002215-80-HU
- Lead Sponsor
- Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 360
Screening visit if week 12 visit of study 200 is > 4 weeks from the first visit of this study (201).
1. Have completed 12 weeks of treatment for Protocol 3140A1-200-WW.
2. Negative serum b-human chorionic gonadotropin (b-HCG) pregnancy test at screening for all women of childbearing potential. A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who are using contraceptives, have had a tubal ligation or whose sexual partners are either sterile or using contraceptives.
3. Sexually active women of childbearing potential must agree and commit to use of a medically acceptable form of contraception and for at least 12 weeks after the last dose of test article. Medically acceptable forms of contraception include sexual abstinence, oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception.
4. Sexually active men must agree and commit to use a medically accepted form of contraception during the study and for at least 12 weeks after the last dose of test article.
5. Stable dose of methotrexate (7.5 to 20 mg) 4 weeks prior to baseline visit.
6. Stable dose of 1 NSAID for at least 2 weeks prior to baseline visit.
7. Stable dose of prednisone, or its equivalent (not more than 10 mg/day) for at least 2 weeks prior to the baseline visit.
8. No inta-articular corticosteroid injection or bolus intramuscular or intravenous treatment with corticosteroid (>20 mg prednisone or equivalent).
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. Subjects who did not complete 12 weeks of test article treatment in the Protocol 3140A1-200-WW trial.
2. Largely or wholly incapacitated with the subject bedridden or confined to a wheelchair, permitting limited or no self-care (ACR Functional Class IV, 1987).
3. Any clinically relevant protocol violation observed during the course of the Protocol 3140A1-200-WW.
4. Abnormal haematology or chemistry profiles: white blood cell count = 3.5 x 109 /L; haemoglobin = 85 g/L or 5.3 mmol/L; haematocrit = 27%; platelet count = 125 x 109 /L or = 1000 x10 9/L; serum creatinine = 175 mmol/L (= 2.0mg/dL); total bilirubin > 1.5 times the ULN, aspartate aminotransferase AST/SGOT) and alanine aminotransferase (ALT) = 1.2 times the laboratory’s upper limit of normal at Baseline.
5. Any use of anti-TNF alpha biologics, rituximab, receipt of any anti-CD4 or diphtheria interleukin-2 fusion protein or other immunosuppressive biologics (except for anakinra).
6. Within 4 weeks before baseline, receipt of the following DMARDs: hydroxychloroquine, chloroquine, sulfasalazine, auronofin, and intramuscular gold, cyclosporine, azathioprine, leflunomide,D-penicillamine and anakinra.
7. Within 4 weeks before baseline receipt of any investigational drug (except for test article received in study 3140A1-200-WW) or investigational biological agent. Within 12 weeks before the baseline visit, receipt of an investigational agent that is unknown.
8. Within 8 weeks before baseline, receipt of any live (attenuated) vaccines.
9. Within 24 weeks before baseline, receipt of cyclosphosphamide.
10. Clinically relevant concurrent medical events including:
- uncompensated congestive heart failure.
- diagnosis of multiple sclerosis or other central demyelinating diseases.
- presence or history of confirmed blood dyscrasias.
- cancer or history of cancer (other than resected cutaneous basal cell or squamous cell carcinoma).
- serious infection (infection association with hospitalization and/or intravenous antibiotics) within 4 weeks of test article administration or active infection at Baseline visit.
- any condition that, in the physician’s judgment, might cause this study to be detrimental to the subject.
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