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

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.