EUCTR2022-001828-15-BG进行中（未招募）1 期
A double-blind, multi-center, randomized, placebo-controlled study of the safety and efficacy of 12 weeks extended treatment with AP1189 in early rheumatoid arthritis (RA) patients naïve to DMARD treatment -EXPAND
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 132
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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 and are ACR class I-III (See Section 22.1)
- •4. = 6 swollen joints (based on 66 joint counts) and = 6 tender joints (based on 68 joint counts). For participants participating in the MRI sub-study, at least one affected joint must be in the hand/wrist.
- •5. Candidate for MTX treatment
- •6. Is about to begin treatment with MTX
- •7. Must meet at least one of the following parameters at Screening:
- •a) A positive result for anti-Cyclic Citrullinated Peptide (anti-CCP) or rheumatoid factor (RF)
- •b) Serum CRP = 6 mg/L
- •8. Highly active RA (CDAI > 22) at screening and baseline
- •9. Negative QuantiFERON-in-Tube test (QFG-IT) (Mantoux test can be used if QFG-IT is not possible)
- •10. Subjects should be able to complete (read and write) the Patient-Reported Outcome questionnaires (PRO questionnaires)
- •11. Females of child-bearing potential may only participate if using a highly effective method of contraception (for detailed information see section22.3) 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 92
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •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 systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis or Felty’s syndrome). Sjögren’s 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. Use of hydroxychloroquine within 4 weeks prior the Screening Visit
- •8. Initiation of, or change in existing NSAID treatment (including COX-2-inhibitors) within 2 weeks prior to the baseline visit
- •9. Corticosteroids except inhaled or nasal formulations for seasonal allergy or asthma are prohibited within 2 weeks prior to screening
- •10. Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal,
- •hepatic, endocrine (including uncontrolled diabetes mellitus), or gastrointestinal disease
- •11. 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)
- •12. Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease where flares are commonly treated with oral or parenteral
- •corticosteroids
- •13. Evidence of active malignant disease (except basal cell carcinoma of the skin that has been excised and cured)
- •14. Pregnant women or nursing (breastfeeding) women
- •15. History of alcohol, drug, or chemical abuse within the 6 months prior to screening
- •16. Neuropathies or other painful conditions that might interfere with pain evaluation
- •17. Body weight of >150 kg
- •18. HBsAg positive and/or Anti-HBc with sign of current infection. Participants with positive Anti-HBc should be tested for IgM anti-HBc - if
- •IgM anti-HBc is positive the patient will be excluded.
- •For participants in the MRI sub-study, additional exclusion criteria apply, as specified in the protocol text.
研究者
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