A Blinded, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer (Ferric Carboxymaltose) in the Treatment of Iron Deficient Patients With Fibromyalgia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Proportion of Patients With a ≥13 Point Improvement in FIQR Score
研究概览
简要总结
This study investigates the efficacy and safety of an IV iron Injectafer in the treatment of iron deficient patients with fibromyalgia. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5. All treated subjects will be followed for efficacy and safety for 42 days.
详细描述
This is a blinded, randomized, placebo-controlled study. All subjects who meet the inclusion requirements and no exclusion criteria will be entered into an up to 14 day screening phase. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5. All treated subjects will be followed for efficacy and safety for 42 days. Subjects will visit the clinic on days 0 and 5 for treatment, and then on days 14, 28, and 42. The subject's participation in the study will be for approximately 42 days from day 0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Male or female subject's ≥ 18 years of age, able to give informed consent to the study.
- •Fibromyalgia diagnosis based on The 2011 modification of the American College of Rheumatology (ACR) 's 2010 preliminary criteria for diagnosing fibromyalgia (2011ModCr)
- •A baseline score ≥ 60 on the FIQR
- •Subject's current medications to treat fibromyalgia, including pain medicines, anti-depressants, sleep medications must be on a stable dose for at least 30 days.
- •Subject's current narcotic medication must be on a stable dose for at least 30 days prior to randomization
- •Subjects at risk for pregnancy must have a negative pregnancy test at baseline and be practicing an acceptable form of birth control: have had a hysterectomy or tubal ligation, or otherwise be incapable of pregnancy, or have practiced any of the following methods of contraception for at least one month prior to study entry: hormonal contraceptives, spermicide and barrier, intrauterine device, partner sterility.
排除标准
- •Parenteral iron use within 4 weeks prior to screening.
- •History of > 10 blood transfusions in the past 2 years.
- •Anticipated need for blood transfusion during the study.
- •Known hypersensitivity reaction to any component of Injectafer® (Ferric Carboxymaltose).
- •Current or acute or chronic infection other than viral upper respiratory tract infection
- •Malignancy (other than basal or squamous cell skin cancer or the subject has been cancer free for ≥ 5 years).
- •Active inflammatory arthritis (e.g. rheumatoid arthritis, SLE).
- •Pregnant or lactating women.
- •Severe peripheral vascular disease with significant skin changes.
- •Seizure disorder currently being treated with medication.
- •Baseline ferritin ≥ 50 ng/mL.
- •Baseline TSAT ≥ 20%.
- •History of hemochromatosis or hemosiderosis or other iron storage disorders.
- •Known positive hepatitis with evidence of active disease.
- •Hemoglobin greater than the upper limit of normal.
- •Calcium or phosphorous outside the normal range.
- •Known positive hepatitis B antigen (HBsAg) or hepatitis C viral antibody (HCV) with evidence of active hepatitis (i.e., AST/ALT greater than the upper limit of normal).
- •Known positive HIV-1/HIV-2 antibodies (anti-HIV)
- •Received an investigational drug within 30 days before randomization.
- •Chronic alcohol or drug abuse within the past 6 months.
- •Any other pre-existing laboratory abnormality, medical condition or disease which in view of the investigator participation in this study may put the subject at risk.
- •Subject unable to comply with the study requirements.
研究组 & 干预措施
Injectafer
15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute
干预措施: Injectafer (Drug)
Placebo
15 cc of Normal Saline IV push at 2 ml/minute
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Patients With a ≥13 Point Improvement in FIQR Score
时间窗: Day 42
The primary efficacy endpoint was the percentage of subjects who had a ≥13-point improvement in the FIQR from baseline to Day 42.
次要结局
- Change in BPI, Pain Interference(Change from Baseline in Brief Pain Inventory Pain Interference Score at Day 42)
- Change in Iron Indices, Serum Ferritin(Change from Baseline in Iron Indices, Serum ferritin at Day 42)
- Change in Iron Indices - Transferrin Saturation(Change from baseline in Iron Indices, Transferrin saturation, at Day 42)
- Change in BPI, Pain Severity(Change from Baseline in Brief Pain Inventory Pain Severity Score at Day 42)
- Change in FIQR Score(Change from Baseline in FIQR score at Day 42)
- Change in Fatigue Visual Numeric Scale(Change from Baseline in Fatigue Visual Numeric Scale at Day 42)