EUCTR2019-001185-15-DK进行中（未招募）1 期
A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 135
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study. The following are requirements for entry into the study.
- •1.Written informed consent has been obtained prior to initiating any study specific procedures
- •2.Male and female subjects, 18 to 85 years of age
- •3.Confirmed diagnosis of RA according to the 2010 ACR/EULAR RA classification criteria
- •4.Arthritis with joint swelling and tenderness of a minimum of three joints out of 68 joints tested
- •5.Candidate for MTX treatment
- •6.Is about to begin treatment with MTX
- •7.Tested positive for anti-CCP or RF
- •8.Severe active RA (CDAI > 22) at screening and baseline
- •9.Negative QFG-IT (Mantoux test can be used if QFG-IT is not possible)
- •10.Subjects should be able to complete (read and write) the PRO questionnaires
- •11.Females of child-bearing potential may only participate if using reliable means of contraception (for detailed information see section 17.8) or are post-menopausal (menstrual periods stopped at least 12 months ahead of the enrolment in the trial). Surgically sterilized women at least 6 months prior to screening
- •12.Females of childbearing potential must have a negative pregnancy test at screening and baseline.
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •Subjects meeting any of the following criteria are not eligible for participation in the study:
- •1.Participation in any other study involving investigational drug(s) within 4 weeks prior to study entry
- •2.Major surgery (including joint operation) within 8 weeks prior to screening or planned surgery within 1 month following randomization
- •3.Rheumatic autoimmune disease other than RA, including SLE, MCTD, scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis or Felty’s syndrome). Sjögren syndrome with RA is allowable
- •4.Functional class IV as defined by the ACR Criteria for Classification of Functional Status in RA or wheelchair/bedbound
- •5.Prior history of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease)
- •6.Subjects with fibromyalgia
- •7.Initiation or change in dose for NSAIDs (including low-dose aspirin and COX-2 inhibitors) within 2 weeks prior to dosing with the IMP
- •8.Corticosteroids are prohibited within 2 weeks prior to screening (and during the entire treatment period and until the final visit (Visit 7)
- •9.Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), or gastrointestinal disease
- •10.Have prior renal transplant, current renal dialysis or severe renal insufficiency (determined by a derived glomerular filtration rate (GFR) using Cockcroft Gault formula of =30 ml/min/1,73m² calculated by the local lab)
- •11.Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
- •12.Evidence of active malignant disease (except basal cell carcinoma of the skin that has been excised and cured)
- •13.Pregnant women or nursing (breastfeeding) mothers
- •14.History of alcohol, drug, or chemical abuse within the 6 months prior to screening
- •15.Neuropathies or other painful conditions that might interfere with pain evaluation
- •16.Body weight of >150 kg.
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