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

NCT02409459 | Completed Phase 2 Results

• 1 other identifier: 1VIT14038
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency; Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in BPI, Pain Interference

  Change from Baseline in Brief Pain Inventory Pain Interference Score at Day 42

• Change in FIQR Score

  Change from Baseline in FIQR score at Day 42

• Change in BPI, Pain Severity

  Change from Baseline in Brief Pain Inventory Pain Severity Score at Day 42

• Change in Fatigue Visual Numeric Scale

  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

Study Arms (2)

Injectafer

EXPERIMENTAL

15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute

Drug: Injectafer

Placebo

PLACEBO COMPARATOR

15 cc of Normal Saline IV push at 2 ml/minute

Drug: Placebo

Interventions

Injectafer DRUG

Also known as: Ferric Carboxymaltose (FCM)

Injectafer

Placebo DRUG

Normal saline solution

Also known as: Saline solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• American Regent, Inc.: lead

Study Sites (1)

Clinical Research Solutions

Franklin, Tennessee, 37064, United States

Location

Related Publications (1)

• 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.

  PMID: 29149437 DERIVED

MeSH Terms

Conditions

Iron Deficiencies; Fibromyalgia

Interventions

ferric carboxymaltose; Saline Solution

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Mark A. Falone, MD
• Organization: Luitpold Pharmaceuticals, Inc.

mfalone@luitpold.com

610.650.4200

Study Officials

• Mark A Falone, MD

  American Regent, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 6, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: March 1, 2016
• Last Updated: February 20, 2018
• Results First Posted: December 13, 2017

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)