NCT02722044已完成3 期
An Open-label Single-arm Multicenter Study to Evaluate Usability of a Subcutaneous (SC) Autoinjector (AI) for a Proposed Adalimumab Biosimilar (M923) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 14
- 主要终点
- Usability of the Auto-injector (AI) at Week 4
研究概览
简要总结
The purpose of this study is to evaluate the usability of an auto-injector (AI) for the delivery of M923 in patients with rheumatoid arthritis (RA)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants ≥18 years old at the time of Screening
- •Able to understand and communicate with the Investigator and comply with the requirements of the study, and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations.
- •RA diagnosed for at least 6 months before Screening
- •Meets classification criteria for rheumatoid arthritis (RA) by 2010 American College of Rheumatology/European League Against Rheumatism criteria
- •Active disease at Screening and Baseline
- •Participants must have at least 1 documented swollen and/or tender joint in their hand or wrist of the dominant hand as assessed by the Investigator or designated assessor
- •Must be willing and able to attempt self-administration of subcutaneous (SC) injection(s)
- •Male participants and their female partners must be willing to comply with the contraception restrictions for this study from the time of the first administration of investigational product (IP) until 3 months after the last dose.
- •Female participants must have a negative pregnancy test at screening and on admission to the clinic, and must not be lactating and must be using an acceptable method of contraception throughout the study and for 3 months after the last dose, or be of non-childbearing potential. Non-pregnant female partners of male participants who are of childbearing potential should use an effective form of contraception.
排除标准
- •Prior use of systemic tumor necrosis factor (TNF) inhibitor therapy.
- •Prior use of rituximab
- •Prior use of abatacept, tocilizumab and tofacitinib within 4 weeks prior to Screening
- •Current use of a conventional disease modifying anti-rheumatic drugs (DMARD) other than the following: methotrexate orally (≤25 mg/day), hydroxychloroquine (≤400 mg/day) or sulfasalazine (≤3 g/day)) at a stable dose for at least 4 weeks prior to Screening. If discontinued, methotrexate, hydroxychloroquine, and sulfasalazine must have been discontinued at least 4 weeks prior to Baseline. No other conventional DMARDs are permitted and no combination therapy is permitted.
- •Prior use of cytotoxic or alkylating agents or immunosuppressants must have been discontinued for at least 90 days prior to Baseline
- •Current use of oral corticosteroids at a dose >10 mg/day prednisone or equivalent or change of dose within 2 weeks prior to Screening
- •Current use of more than 1 nonsteroidal anti-inflammatory drug.
- •Prior use of injectable corticosteroids (intramuscular [IM], intra-articular [IA], or intravenous [IV]) within 6 weeks prior to Baseline
- •Prior or current use of other self-injected drugs, eg, insulin
- •All other prior non-RA concomitant treatments must be on a stable dose for at least 4 weeks before Baseline
- •Meets Class IV Steinbrocker criteria for disability/activities of daily living
- •Laboratory abnormalities at Screening deemed clinically significant by the Investigator and/or Sponsor.
- •Presence of fibromyalgia, another autoimmune rheumatologic illness or inflammatory arthritis, eg, systemic lupus erythematosus, gout. The presence of secondary Sjogren's syndrome is permitted.
- •Joint surgery within the last 8 weeks prior to Screening
- •Severe, progressive, or uncontrolled renal, hepatic, metabolic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac or neurologic disease, including pleural effusions or ascites, which in the opinion of the Investigator would preclude the participant from adhering to or completing the study or where participation in the study exposes the participant to unfavorable benefit/risk
- •History or presence of signs and/or symptoms or a diagnosis of a demyelinating disorder
- •History or presence of Class III or IV New York Heart Association congestive heart failure
- •History or presence of symptoms suggestive of lymphoproliferative disorders, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma
- •Existing malignancy or history of any malignancy except adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ, with no more than 3 lifetime basal cell or squamous cell carcinomas
- •Chronic infections, recurrent infections (3 or more of the same infection requiring anti-infective treatment in any rolling 12-month period); any recent infection (ie, in the last 30 days) requiring hospitalization or any infection requiring parenteral anti-infective therapy within 30 days or oral infective therapies within 14 days of Baseline; herpes zoster within 6 months of Baseline or more than 2 lifetime episodes of herpes zoster; or history of systemic fungal infection or opportunistic infection (eg, coccidioidomycosis, histoplasmosis, toxoplasmosis)
- •History or presence of human immunodeficiency virus (HIV), Hepatitis B or C virus
- •History of active tuberculosis (TB) or untreated or inadequately treated latent TB.
- •Participant has been exposed to an investigational product (IP) within 30 days (or 5 half-lives) prior to enrollment, whichever is longer, or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
- •Participant is a family member or employee of the Investigator or Baxalta or its partners
研究组 & 干预措施
All Study Participants
Experimental
All study participants to receive M923 administered via a subcutaneous auto-injector (AI)
干预措施: Autoinjector (Device)
All Study Participants
Experimental
All study participants to receive M923 administered via a subcutaneous auto-injector (AI)
干预措施: M923 (Biological)
结局指标
主要结局
Usability of the Auto-injector (AI) at Week 4
时间窗: Week 4
The primary usability measure was the participant rating captured in the PRE- and POST-Self-injection Assessment Questionnaire (SIAQ) modules at Week 4. The PRE-SIAQ module is a 7-item questionnaire that investigates feelings about injections, self-confidence (regarding self-administration), and satisfaction with self-injection. The POST-SIAQ module is a 27-item questionnaire that assesses feelings about injections, self-image, self-confidence (regarding self-administration), pain and skin reactions during or after injection (injection-site reactions), ease of use of the self-injection device, and satisfaction with self-injection. Participants rated each item of the SIAQ on a 5-point (or 6-point) semantic Likert-type scale, where a score of 1 corresponds to a participant's worst experience and a score of 5 (or 6) corresponds to a participant's best experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience) for each item.
次要结局
- Number of Participants With Successful Injections as Assessed by the Observer at Baseline(Baseline (Day 1))
- Number of Participants With Successful Injections as Assessed by the Observer at Week 2(Week 2)
- Number of Participants With Hazard-free Injections as Assessed by the Observer at Week 2(Week 2)
- Usability of the Auto-injector at Week 2(Week 2)
- Number of Participants With Successful Injections as Assessed by the Observer at Week 4(Week 4)
- Number of Participants With Hazard-free Injections as Assessed by the Observer at Week 4(Week 4)
- Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 4(Week 4)
- Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 12(Week 12)
- Number of Participants With Hazard-free Injections as Assessed by the Observer at Baseline(Baseline (Day 1))
- Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments(Baseline; 32 Weeks)
- Number of Participants With Treatment-emergent Injection Site Reactions(32 Weeks)
- Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at the Safety Follow-Up Visit(Safety Follow-Up Visit (32 Weeks))
- Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 12(Week 12)
- Usability of the Auto-injector at Baseline(Baseline (Day 1))
- Number of Participants With Vital Signs Outside the Expected Range(32 Weeks)
- Number of Participants With Adverse Events Leading to Premature Study Withdrawal(32 Weeks)
- Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of Anti-drug Antibodies (ADAs) at Baseline(Baseline (Day 1))
- Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 4(Week 4)
- Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 24(Week 24)
- Number of Participants With Clinically Significant Changes in Twelve-lead Electrocardiogram (ECG) Findings(Baseline; 32 Weeks)
- Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 24(Week 24)
- Immunogenicity of M923 Assessed as the Number of Participants With Neutralizing Anti-drug Antibodies (nADAs) at Baseline(Baseline (Day 1))
- Immunogenicity of M923 Assessed as the Number of Participants With nADAs at the Safety Follow-Up Visit(Safety Follow-Up Visit (32 Weeks))
研究者
研究点 (14)
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