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

Primary Purpose

Iron Deficiency, Fibromyalgia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Injectafer

Placebo

About this trial

This is an interventional treatment trial for Iron Deficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Clinical Research Solutions

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Injectafer

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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 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 in Fatigue Visual Numeric Scale

Scores range from 0 to 10, with the higher score indicating more fatigue.

Change in Iron Indices, Serum Ferritin

Change in Iron Indices - Transferrin Saturation

Full Information

NCT ID

NCT02409459

First Posted

April 1, 2015

Last Updated

January 22, 2018

Sponsor

American Regent, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02409459

Brief Title

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

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

March 2015 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

American Regent, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Iron Deficiency, Fibromyalgia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Injectafer

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Injectafer

Other Intervention Name(s)

Ferric Carboxymaltose (FCM)

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Saline solution

Intervention Description

Normal saline solution

Primary Outcome Measure Information:

Title

Proportion of Patients With a ≥13 Point Improvement in FIQR Score

Description

The primary efficacy endpoint was the percentage of subjects who had a ≥13-point improvement in the FIQR from baseline to Day 42.

Time Frame

Day 42

Secondary Outcome Measure Information:

Title

Change in BPI, Pain Interference

Description

Time Frame

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

Title

Change in FIQR Score

Description

Time Frame

Change from Baseline in FIQR score at Day 42

Title

Change in BPI, Pain Severity

Description

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.

Time Frame

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

Title

Change in Fatigue Visual Numeric Scale

Description

Scores range from 0 to 10, with the higher score indicating more fatigue.

Time Frame

Change from Baseline in Fatigue Visual Numeric Scale at Day 42

Title

Change in Iron Indices, Serum Ferritin

Time Frame

Change from Baseline in Iron Indices, Serum ferritin at Day 42

Title

Change in Iron Indices - Transferrin Saturation

Time Frame

Change from baseline in Iron Indices, Transferrin saturation, at Day 42

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark A Falone, MD

Organizational Affiliation

American Regent, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Clinical Research Solutions

City

Franklin

State/Province

Tennessee

ZIP/Postal Code

37064

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

29149437

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.

Results Reference

derived

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

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