Iron DeficiencyPhase 2NCT02409459
Blinded Randomized Placebo-Controlled Study Efficacy and Safety of Injectafer in ID Patients With Fibromyalgia
A Phase 2 study testing Injectafer in people with Iron Deficiency and Fibromyalgia, run by American Regent, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency, Fibromyalgia
- What is being tested?
- Injectafer
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Mar 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Solutions
Franklin, Tennessee, 37064
About this study
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
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.
Read the 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.
- Conditions
- Iron Deficiency, Fibromyalgia
- Being tested
- Injectafer, Placebo
- Medical subject headings
- Iron Deficiencies, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InjectaferDrug
Also called Ferric Carboxymaltose (FCM)
PlaceboDrug
Also called Saline solution
Normal saline solution
| Study group | Role | What they receive |
|---|---|---|
| Injectafer | Experimental | 15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute Receives: Drug: Injectafer |
| Placebo | Placebo comparator | 15 cc of Normal Saline IV push at 2 ml/minute Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 42
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline in Fatigue Visual Numeric Scale at Day 42
Change in Iron Indices, Serum Ferritin
Measured: Change from Baseline in Iron Indices, Serum ferritin at Day 42
Change in Iron Indices - Transferrin Saturation
Measured: Change from baseline in Iron Indices, Transferrin saturation, at Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Regent, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark A Falone, MD, Study director, American Regent, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409459
- Sponsor's protocol ID
- 1VIT14038
- Status last verified
- Jan 2018
- First submitted
- 1 Apr 2015
- Last updated
- 20 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 29149437
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02409459
- Acronym / sponsor ID
- 1VIT14038
- Conditions
- Iron Deficiency, Fibromyalgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- American Regent, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 6 Apr 2015 (estimated)
- Results
- Posted 13 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injectafer | Experimental | Drug: Injectafer15 mg/kg up to 750 mg undiluted blinded dose of IV Injectafer (ferric carboxymaltose) at 100 mg/minute |
| Placebo | Placebo comparator | Drug: Placebo15 cc of Normal Saline IV push at 2 ml/minute |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InjectaferAlso: Ferric Carboxymaltose (FCM) | Drug | Injectafer |
| PlaceboAlso: Saline solutionNormal saline solution | Drug | Placebo |
Primary outcome
Proportion of Patients With a ≥13 Point Improvement in FIQR Score
Time frame: Day 42
The primary efficacy endpoint was the percentage of subjects who had a ≥13-point improvement in the FIQR from baseline to Day 42.
6 secondary outcomes
Change in BPI, Pain Interference
Time frame: Change from Baseline in Brief Pain Inventory Pain Interference Score at Day 42
Change in FIQR Score
Time frame: Change from Baseline in FIQR score at Day 42
Change in BPI, Pain Severity
Time frame: Change from Baseline in Brief Pain Inventory Pain Severity Score at Day 42
Change in Fatigue Visual Numeric Scale
Time frame: Change from Baseline in Fatigue Visual Numeric Scale at Day 42
Change in Iron Indices, Serum Ferritin
Time frame: Change from Baseline in Iron Indices, Serum ferritin at Day 42
Change in Iron Indices - Transferrin Saturation
Time frame: Change from baseline in Iron Indices, Transferrin saturation, at Day 42
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29149437Boomershine 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A Falone, MD study director
American Regent, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Injectafer in people with Iron Deficiency and Fibromyalgia, run by American Regent, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With a ≥13 Point Improvement in FIQR Score (time frame: Day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02409459, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2018.