EUCTR2010-021184-32-PL进行中（未招募）1 期
A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs andone or up to three anti-TNF therapies
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Hexal AG
- 入组人数
- 124
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
- •Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- •1. Patients must give written informed consent before any study-related assessment is performed.
- •2. Patients must be = 18 years of age.
- •3. Patients must have a diagnosis of Rheumatoid Arthritis, based on the ACR 1987 criteria.
- •At least 4 of the following 7 criteria must be fulfilled (and criteria a. through d. must have been present for at least 6 weeks) to confirm the diagnosis of RA:
- •a. joint morning stiffness of at least one hour
- •b. swelling of joints in at least three joint areas, diagnosed by a doctor, c. swelling of MCP and wrist joints, diagnosed by a doctor
- •d. bilateral, symmetric swelling of joints in the same joint areas, diagnosed by a doctor
- •e. rheumatoid nodule
- •f. rheumatoid factor seropositivity
- •g. positive findings in hand radiographs.
- •4. Patients must have had the diagnosis of RA for at least 6 months at Visit 2.
- •5. Patients must have active RA at baseline (Visit 2):
- •= 6 swollen joints (of 66 joints assessed)
- •= 6 tender joints (of 68 joints assessed)
- •CRP = 10 mg/L
- •ORESR = 28 mm/1st hour
- •Note: If one of the above criteria is not met at Visit 2, the patient is not eligible for randomization at this time point. A re-assessment (i.e., an additional Visit 2) can be done once within 14 days at the discretion of the investigator. A patient can repeat the whole screening phase (be re-screened) only once.
- •6. Patients must be seropositive for rheumatoid factor (RF) and/or have antibodies to cyclic citrullinated peptide (anti-CCP) at Visit 1.
- •For additional inclusion criteria, please refer to section 4.1 of the protocol.
- •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 99
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Patients eligible for inclusion in this study must not fulfill any of the following criteria:
- •1. RA patients with functional status class IV classified according to the ACR 1991 revised criteria.
- •2. Patients with levels of serum IgG, IgM and IgA below LLN at Visit 1 and/or Visit 2.
- •3. Patients with systemic manifestations of RA, with the exception of Sjögren’s syndrome.
- •4. Patients taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine).
- •5. Female patients nursing (lactating / breast-feeding), pregnant or planning of pregnancy within 12 months after the last infusion of study drug, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (cut-off as defined by the central laboratory).
- •6. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and intrauterine devices (IUDs)). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.
- •7. Patients who have had any therapy with intra-articular injections (e. g. corticoid) required by a flare up to 4 weeks before randomization.
- •For additional exclusion criteria, please refer to section 4.2 of the protocol.
研究者
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