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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Iron Deficiency, Fibromyalgia

Intervention / Treatment
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* Drug: Injectafer
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injectafer<br>15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute | Drug: Injectafer<br> <br> * Other names: Ferric Carboxymaltose (FCM);|
| Placebo Comparator: Placebo<br>15 cc of Normal Saline IV push at 2 ml/minute | Drug: Placebo<br>* Normal saline solution<br>* Other names: Saline solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients With a ≥13 Point Improvement in FIQR Score | The primary efficacy endpoint was the percentage of subjects who had a ≥13-point improvement in the FIQR from baseline to Day 42. | Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BPI, Pain Interference | The short version of the Brief Pain Inventory (BPI) includes front and back body diagrams, 4 pain severity items and 7 pain interference items rated on 0-10 scales (with 0 being the best outcome and 10 being the worst outcome), and a question about percentage of pain relief by analgesics. The Pain Interference Score is calculated by adding the scores for the 7 pain interference questions and then dividing by 7 to give a score out of 10. | Change from Baseline in Brief Pain Inventory Pain Interference Score at Day 42 | 
| Change in FIQR Score | The FIQR has 21 individual questions. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst' and all questions are framed in the context of the past 7 days. The summed score for function (range 0 to 90) is divided by 3, the summed score for overall impact (range 0 to 20) is not changed, and the summed score for symptoms (range 0 to 100) is divided by 2. The total FIQR is the sum of the three modified domain scores. | Change from Baseline in FIQR score at Day 42 | 
| Change in BPI, Pain Severity | The short version of the Brief Pain Inventory (BPI) includes front and back body diagrams, 4 pain severity items and 7 pain interference items rated on 0-10 scales (with 0 being the best outcome and 10 being the worst outcome), and a question about percentage of pain relief by analgesics. The Pain Severity Score is calculated by adding the scores for the 4 pain severity questions and then dividing by 4 to give a severity score out of 10. | Change from Baseline in Brief Pain Inventory Pain Severity Score at Day 42 | 
| Change in Fatigue Visual Numeric Scale | Scores range from 0 to 10, with the higher score indicating more fatigue. | Change from Baseline in Fatigue Visual Numeric Scale 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 |