A 26-week, phase II, multi-center, randomized, doubleblind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - ND
- Conditions
- Early rheumatoid arthritisMedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
- Registration Number
- EUCTR2006-001553-10-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 87
1. Male and post-menopausal or surgically sterilized female patients aged 18-75 years, having provided a written informed consent and passed screening examinations. 2. Women of child-bearing potential may participate if they have a negative serum pregnancy test at screening and prior to dosing, and are willing to practice double-barrier contraception during the study (from the date of screening) and for at least 3 months following the last dose. 3. Weight >= 45 kg, body mass index (BMI) <= 34. 4. Patient has a recent definite diagnosis of RA (less than 3 years since diagnosis), classified by ARA (American Rheumatism Association) 1987 revised criteria. 5. Candidate for methotrexate or biologic due to erosive arthritis, with no contraindications to such therapy, including: a. Negative tuberculin skin test reaction (PPD 5 TU) (< 5 mm induration) at 48 to 72 hours after administration at the screening visit or within 2 months prior to the screening visit, according to national guidelines. Patients who have a positive PPD skin test, but were previously treated with anti-tuberculosis drugs, or are known to have a negative chest X-ray (within the last year) can be included (see Appendix describing most recent CDC guidelines to manage risk of TB reactivation, to assure source documentation that patient is at low risk). b. Normal chest X-ray (within the last year) prior to possibility of receiving MTX (r/o lung fibrosis). 6. Functional status class I, II or III classified according to the ACR (American College of Rheumatology) 1991 revised criteria. 7. Patient presents active disease at screening and baseline evaluation (same evaluator), defined as at least 6 swollen and 6 painful tender joints of 28 joint count, hsCRP >= 1.0 mg/dL, and/or ESR > 28 mm/h. 8. Oral corticosteroids are permitted as long as patients are on a stable dose (up to 10 mg) for at least 4 weeks.
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. Contraindication for MRI of wrist / MCP joints. 2. Patients with magnetizable metal parts/devices on and in the body. 3. Patients with an unstable active medical condition likely to impair evaluation of safety and biomarker results. 4. Previous treatment with biological therapy or MTX. 5. Previous treatment with other disease-modifying anti-rheumatic drugs (DMARDS) such as sulfasalazine, hydroxychloroquine within 4 weeks of screening 6. Intra-articular corticosteroids within 4 weeks prior to screening.
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