Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With Fibromyalgia

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

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.

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.