Clinical trial NCT02409459: Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With Fibromyalgia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Iron Deficiency
Fibromyalgia
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-06
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Proportion of Patients With a ≥13 Point Improvement in FIQR Score
timeFrame: Day 42
Secondary outcomes:
measure: Change in BPI, Pain Interference
timeFrame: Change from Baseline in Brief Pain Inventory Pain Interference Score at Day 42
measure: Change in FIQR Score
timeFrame: Change from Baseline in FIQR score at Day 42
measure: Change in BPI, Pain Severity
timeFrame: Change from Baseline in Brief Pain Inventory Pain Severity Score at Day 42
measure: Change in Fatigue Visual Numeric Scale
timeFrame: Change from Baseline in Fatigue Visual Numeric Scale at Day 42
measure: Change in Iron Indices, Serum Ferritin
timeFrame: Change from Baseline in Iron Indices, Serum ferritin at Day 42
measure: Change in Iron Indices - Transferrin Saturation
timeFrame: Change from baseline in Iron Indices, Transferrin saturation, at Day 42
Other outcomes:
Locations:
city: Franklin
country: United States
facility: Clinical Research Solutions
state: Tennessee
Study officials:
affiliation: American Regent, Inc.
name: Mark A Falone, MD
role: STUDY_DIRECTOR
References:
citation: Boomershine CS, Koch TA, Morris D. A Blinded, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Ferric Carboxymaltose in Iron-Deficient Patients with Fibromyalgia. Rheumatol Ther. 2018 Jun;5(1):271-281. doi: 10.1007/s40744-017-0088-9. Epub 2017 Nov 17.