EUCTR2016-002126-36-ES进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, multi-center phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 204
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
- •- Adult men and women, 18 to 80 years of age (inclusive)
- •- Diagnosis of adult-onset RA as defined by the American College of Rheumatology (ACR) 2010 criteria, for at least 6 months before screening
- •- Moderately to severely active RA as defined by at least 4/28 tender joints and at least 4/28 swollen joints
- •- For Part 2 only: Active synovitis and/or osteitis of the dominant hand/wrist as determined by MRI
- •- Patients must be taking one of the following anti-TNF-a therapies: certolizumab, golimumab, etanercept, adalimumab or approved biosimilars of these, given at an approved and stable dose for at least 12 weeks before randomization, and have experienced in the opinion of the Investigator an inadequate response to anti-TNF-a therapy with a DAS28 => 3.2
- •- Patients must be taking MTX (PO, SC, or IM) for at least 12 weeks before randomization and must be on a stable dose for at least 4 weeks before randomization (7.5 to 25 mg/week). The dose of MTX is expected to remain stable throughout the study and may be adjusted only for safety reasons. Local standard-of-care should be followed for concomitant administration of folic acid
- •- Patients on glucocorticoids (<= 10 mg/day PO prednisone or equivalent) are permitted if doses are stable within 6 weeks of planned randomization
- •- Patients taking non-steroidal anti-inflammatory drugs (NSAIDs) intermittently (e.g., up to 2-3 times weekly) for short-term relief of pain are allowed, and patients on regular NSAID use (i.e., on stable dose for = 4 weeks) are allowed
- •- Negative pregnancy test at screening and baseline (women only), and agreement to comply with measures to prevent pregnancy and restrictions on sperm donation
- •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 174
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- Currently receiving concomitant treatment with sulfasalazine or leflunomide
- •- Patients currently on IV infliximab or an approved IV biosimilar of it are excluded
- •- Parenteral glucocorticoids administration (IM, IV) of =50 mg within 6 weeks prior to planned randomization, or =50 mg within 4 weeks prior to planned randomization, or scheduled parenteral administrations during the study
- •- Joints injected with intra-articular glucocorticoids or hyaluronic acid within 6 weeks prior to planned randomization
- •- Active inflammatory disease of the joints not related to RA
- •- Systemic autoimmune disease other than RA
- •- Juvenile idiopathic arthritis or juvenile RA and/or RA developed before the age of 16
- •- Active fibromyalgia that makes appropriate assessment of RA disease activity challenging in the opinion of the Investigator
- •- RA patients functional status class IV according to the American College of Rheumatology (ACR) 1991 criteria (i.e., largely or wholly incapacitated permitting little or no self-care, such as being bedridden or confined to wheelchair)
- •- Patients with severe chronic or recurrent viral, bacterial, parasitic or fungal infections
- •- History of active hepatitis B virus, hepatitis C virus, or human immunodeficiency virus infection
- •- Any identified confirmed congenital or acquired immunodeficiency
- •- Abnormal laboratory test results
- •- Other unstable somatic diseases (apart from RA) that can increase the probability of adverse events during the study or can influence the estimation of symptom manifestation of RA; mask, enhance or alter the symptoms of RA or cause clinical or laboratory symptoms similar to that of RA
- •- Major surgery within 28 days prior to randomization, or requiring major surgery (e.g., elective joint replacement surgery) during the trial
- •- Any mental disorder
- •- Myocardial infarction within less than 6 months prior to participation in the study
- •- Severe central or peripheral nervous system diseases
- •- Chronic drug or alcohol abuse
- •- Known hypersensitivity to any components of the medications used in the study
- •- Acute forms of any infectious diseases or history of chronic infections with severe clinical manifestations
- •- Presence of malignant neoplasm, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ and any malignancy with complete remission of more than 5 years
- •- German sites: Patients who are institutionalized due to regulatory or juridical order
- •- German sites: Patients who are occupationally or medically dependent on the Sponsor, the Investigator, or the medical site
研究者
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