Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With Fibromyalgia
Condition: Iron Deficiency; Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Iron Deficiencies
Intervention: Injectafer; Placebo
Intervention description: Normal saline solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.