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Plaque Psoriasis.Phase 1/2ASISinPPNCT02112097

ASIS for Enbrel in Plaque Psoriasis

A Phase 1/2 study testing Gadolinium, Efficacy of Enbrel subcutaneously at Week 12 and Efficacy of Enbrel subcutaneously at Week 24 in people with Plaque Psoriasis., run by ASIS Corporation at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

AUTOMATIC SUBDERMAL INJECTOR SYSTEM (ASIS) Corporation has developed and patented the only automatic injection system for delivery of injectable products to the optimum spot, just outside of the fascia, which exists subdermally (between the skin and muscle) or interfascial (between the deeper muscles). Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Plaque Psoriasis.
What is being tested?
Gadolinium, Efficacy of Enbrel subcutaneously at Week 12 and Efficacy of Enbrel subcutaneously at Week 24
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesUnited States
Study dates
Jan 2016to Jun 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

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 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Main Criteria for Inclusion: Eligible Ages: 12 Years to 65
  • Genders Eligible for Study: Both
  • Accepts Healthy Volunteers: Yes
  • Must be outpatient, male or female, of any race, between 18 and 65 years of age.
  • Must be able to understand the requirements of the study including maintaining a diary, and sign informed consent.
  • Must be in good general health as determined by investigator.
Show all 10Show fewer
  • If female of childbearing potential, must have negative pregnancy test result at screening visit and practice reliable method of contraception
  • Must have chronic moderate to severe plaque psoriasis and be candidates for systemic therapy or phototherapy.
  • Must have psoriasis involving at least 10% of body surface and a minimum PASI score of 10.
  • Patients are limited to low-moderate-strength topical corticosteroids in axillary, groin, and scalp regions.

Who cannot join

  • Patients with guttate, erythrodermic, or pustular psoriasis and patients with severe infections within 4 weeks of screening are excluded from study.
  • No concomitant major anti-psoriatic therapies are allowed during the study.
  • Has chronic or recurrent infection, has been exposed to tuberculosis, has resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis; or has underlying conditions that may predispose them to infection such as advanced or poorly controlled diabetes

Trial locations and contacts

2 sites in 1 country.

Li Nguyen, MD contact

(714)-453-7857

dr.li.nguyen@asis-inc.com

Thanh Phung, MD contact

714-893-1915

thanhphung@idit-inc.com

United States2 sites

  • Automatic Subdermal Injector System, Inc

    Westminster, California, 92683

    Li Nguyen, MD, 714-453-7857, dr.li.nguyen@asis-inc.com

    Thanh Phung, MD, (714)-893-1915, thanhphung@idit-inc.com

  • Automatic Subdermal Injector System, Inc

    Westminster, California, 92683

Other trials in United States

About this study

AUTOMATIC SUBDERMAL INJECTOR SYSTEM (ASIS) Corporation has developed and patented the only automatic injection system for delivery of injectable products to the optimum spot, just outside of the fascia, which exists subdermally (between the skin and muscle) or interfascial (between the deeper muscles). ASIS device creates that bloodless space, enhancing Enbrel's efficacy and preventing unnecessary distant spread and adverse reactions. This space remains bloodless as long as the skin is lifted up or filled with an injectable product. Although ASIS device was initially designed to best administer BOTOX for such muscular conditions as Upper limb Spasticity, Cervical Dystonia, Chronic Migraine, Strabismus, Blepharospasm, and Primary Axillary Hyperhidrosis, the technology will also benefit other injectable products, including: GAMMAGARD for Primary Immunodeficiency (PI) and Insulin for Diabetics, etc.

Read the detailed description

Over 6 months, Aim 1 will demonstrate that ASIS device consistently delivers an injectable product (e.g. Gadolinium) into that subdermal bloodless space. MRI is the most simple and logical imaging choice, preferred because with ultrasound, air is injected, which will dissipate too quickly out of bloodless space to allow measurements. Since there isn't a way to measure the level of Gadolinium within that subdermal bloodless space, at least the Prolongation of Gadolinium may be approximated by its greater or longer Persistent % on MRI. Also, since we can't assume that bloodless space for patients with a particular disease will behave the same way as normal patients or patients with different diseases, this approximation only works if the variables are minimized to the same particular skin affected by Plaque Psoriasis. Case in point, patients with Plaque Psoriasis tend to have thicker skin, so expectantly will have prolonged Gadolinium subcutaneously Persistent %, which may be very different from the other diseases and certainly from the skin of normal patients, while the Gadolinium subdermally Persistent % should remain the same. Therefore, the Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % subcutaneously, will be different and very specific for the particular skin affected by Plaque Psoriasis. However, they are valuable indicators that will help us modify the Enbrel dosage and duration to inject into that "unknown" subdermal space for Aim 2, from the "known" typical Enbrel dosage and duration for Plaque Psoriasis patients. For example, if Aim 1 found the Relative Prolongation Ability Score for the Plaque Psoriasis skin to be (2.00), then the typical subcutaneously Enbrel 50mg every 3 days, should be 25mg every 6 days subdermally.

Over 12 months, Aim 2 will again demonstrate the advantages of ASIS device injecting subdermally versus subcutaneously, but using Enbrel instead of Gadolinium on the particular skin affected by Plaque Psoriasis. Once we have shown ASIS device's consistent performance in Aim 1, then we may assume will deliver another product (Enbrel) into that bloodless space without the need to measure Enbrel's existent in that bloodless space. Using Enbrel instead of Gadolinium, we'll demonstrate the advantages of injecting subdermally over intramuscularly for the same affected skin sites in the same 60 adult subjects.

Being tested
Gadolinium, Efficacy of Enbrel subcutaneously at Week 12, Efficacy of Enbrel subcutaneously at Week 24, Efficacy of Enbrel subcutaneously at Week 36, Efficacy of Enbrel subdermally at Week 12
Keywords
Plaque Psoriasis., Subdermal bloodless space, Subdermal injection, Subcutaneous injection, Injectable electromyography needle, Electrical stimulation, MRI with Gadolinium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GadoliniumDrug

    Also called Gadolinium Magnevist® (gadopentetate dimeglumine)

    For Left Upper Arm Total Persistent % subdermally, on MRI at 6 hrs, 12 hrs, and 24 hrs.

    Gadolinium Magnevist® (gadopentetate dimeglumine)

    .1cc/ diluted with .9cc normal saline subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients.

  • GadoliniumDrug

    Also called Gadolinium Magnevist® (gadopentetate dimeglumine)

    For Left Upper Arm Total Persistent % subcutaneously, on MRI at 6 hrs, 12 hrs, and 24 hrs.

    Gadolinium Magnevist® (gadopentetate dimeglumine)

    .1cc/ diluted with .9cc normal saline subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients.

  • GadoliniumDrug

    Also called Gadolinium Magnevist® (gadopentetate dimeglumine)

    For Left Upper Arm Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI.

  • Efficacy of Enbrel subcutaneously at Week 12Drug

    Also called Enbrel (etanercept)

    sPGA 50 n(%) as Efficacy of Enbrel subcutaneously at Week 12, in terms of Proportion of patients who achieve a score of "clear" or "minimal" by the Static Physician Global Assessment (sPGA) and the proportion of patients with a reduction of PASI of at least 50% from baseline.

    The sPGA is a 6-category scale ranging from "5 = severe" to "0 = none" indicating the physician's overall assessment of the psoriasis severity focusing on indurations, erythema, and scaling. Treatment success of "clear" or "minimal" consists of none or minimal elevation in plaque, up to faint red coloration in erythema, and none or minimal fine scale over < 5% of the plaque.

  • Efficacy of Enbrel subcutaneously at Week 24Drug

    Also called Enbrel (etanercept)

    sPGA 50 n(%) as Efficacy of Enbrel subcutaneously at Week 24, in terms of Proportion of patients who achieve a score of "clear" or "minimal" by the Static Physician Global Assessment (sPGA) and the proportion of patients with a reduction of PASI of at least 50% from baseline.

    The sPGA is a 6-category scale ranging from "5 = severe" to "0 = none" indicating the physician's overall assessment of the psoriasis severity focusing on indurations, erythema, and scaling. Treatment success of "clear" or "minimal" consists of none or minimal elevation in plaque, up to faint red coloration in erythema, and none or minimal fine scale over < 5% of the plaque.

  • Efficacy of Enbrel subcutaneously at Week 36Drug

    Also called Enbrel (etanercept)

    sPGA 50 n(%) as Efficacy of Enbrel subcutaneously at Week 36, in terms of Proportion of patients who achieve a score of "clear" or "minimal" by the Static Physician Global Assessment (sPGA) and the proportion of patients with a reduction of PASI of at least 50% from baseline.

    The sPGA is a 6-category scale ranging from "5 = severe" to "0 = none" indicating the physician's overall assessment of the psoriasis severity focusing on indurations, erythema, and scaling. Treatment success of "clear" or "minimal" consists of none or minimal elevation in plaque, up to faint red coloration in erythema, and none or minimal fine scale over < 5% of the plaque.

  • Efficacy of Enbrel subdermally at Week 12Drug

    Also called Enbrel (etanercept)

    sPGA 50 n(%) as Efficacy of Enbrel subdermally at Week 12, in terms of Proportion of patients who achieve a score of "clear" or "minimal" by the Static Physician Global Assessment (sPGA) and the proportion of patients with a reduction of PASI of at least 50% from baseline.

    The sPGA is a 6-category scale ranging from "5 = severe" to "0 = none" indicating the physician's overall assessment of the psoriasis severity focusing on indurations, erythema, and scaling. Treatment success of "clear" or "minimal" consists of none or minimal elevation in plaque, up to faint red coloration in erythema, and none or minimal fine scale over < 5% of the plaque.

  • Efficacy of Enbrel subdermally at Week 24Drug

    Also called Enbrel (etanercept)

    sPGA 50 n(%) as Efficacy of Enbrel subdermally at Week 24, in terms of Proportion of patients who achieve a score of "clear" or "minimal" by the Static Physician Global Assessment (sPGA) and the proportion of patients with a reduction of PASI of at least 50% from baseline.

    The sPGA is a 6-category scale ranging from "5 = severe" to "0 = none" indicating the physician's overall assessment of the psoriasis severity focusing on indurations, erythema, and scaling. Treatment success of "clear" or "minimal" consists of none or minimal elevation in plaque, up to faint red coloration in erythema, and none or minimal fine scale over < 5% of the plaque.

  • Efficacy of Enbrel subdermally at Week 36Drug

    Also called Enbrel (etanercept)

    sPGA 50 n(%) as Efficacy of Enbrel subdermally at Week 36, in terms of Proportion of patients who achieve a score of "clear" or "minimal" by the Static Physician Global Assessment (sPGA) and the proportion of patients with a reduction of PASI of at least 50% from baseline.

    The sPGA is a 6-category scale ranging from "5 = severe" to "0 = none" indicating the physician's overall assessment of the psoriasis severity focusing on indurations, erythema, and scaling. Treatment success of "clear" or "minimal" consists of none or minimal elevation in plaque, up to faint red coloration in erythema, and none or minimal fine scale over < 5% of the plaque.

  • PASI 75 n(%) subcutaneously at Week 12Drug

    Also called Enbrel (etanercept)

    PASI 75 n(%) as Efficacy of Enbrel subcutaneously at Week 12, in terms of the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI.

  • PASI 75 n(%) subcutaneously at Week 24Drug

    Also called Enbrel (etanercept)

    PASI 75 n(%) as Efficacy of Enbrel subcutaneously at Week 24, in terms of the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI.

  • PASI 75 n(%) subcutaneously at Week 36Drug

    Also called Enbrel (etanercept)

    PASI 75 n(%) as Efficacy of Enbrel subcutaneously at Week 36, in terms of the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI.

  • PASI 75 n(%) subdermally at Week 12Drug

    Also called Enbrel (etanercept)

    PASI 75 n(%) as Efficacy of Enbrel subdermally at Week 12, in terms of the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI.

  • PASI 75 n(%) subdermally at Week 24Drug

    Also called Enbrel (etanercept)

    PASI 75 n(%) as Efficacy of Enbrel subdermally at Week 24, in terms of the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI.

  • PASI 75 n(%) subdermally at Week 36Drug

    Also called Enbrel (etanercept)

    PASI 75 n(%) as Efficacy of Enbrel subdermally at Week 36, in terms of the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI.

  • Adverse Reactions of Enbrel subcutaneouslyDrug

    Also called Enbrel (etanercept)

    Adverse Reactions of Enbrel subcutaneously at Week 36, in number of Injection site reactions, Heart failure, Allergic Reactions, Blood problems/low blood counts, Nervous system, Infections, Malignancies, Immunogenicity, and Autoantibodies.

  • Adverse Reactions of Enbrel subdermally at Week 36Drug

    Also called Enbrel (etanercept)

    Adverse Reactions of Enbrel subdermally at Week 36, in number of Injection site reactions, Heart failure, Allergic Reactions, Blood problems/low blood counts, Nervous system, Infections, Malignancies, Immunogenicity, and Autoantibodies.

  • GadoliniumDrug

    Also called Gadolinium Magnevist® (gadopentetate dimeglumine)

    For Right Upper Arm Total Persistent % subdermally, on MRI at 6 hrs, 12 hrs, and 24 hrs.

    Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9cc normal saline subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients.

  • GadoliniumDrug

    Also called Gadolinium Magnevist® (gadopentetate dimeglumine)

    For Right Upper Arm Total Persistent % subcutaneously, on MRI at 6 hrs, 12 hrs, and 24 hrs.

    Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9cc normal saline subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients.

  • GadoliniumDrug

    Also called Gadolinium Magnevist® (gadopentetate dimeglumine)

    For Right Upper Arm Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI.

Study groups in NCT02112097
Study groupRoleWhat they receive
For Left Upper ArmExperimentalFor Left Upper Arm Total Persistent % subdermally, For Left Upper Arm Total Persistent % subcutaneously, and For Left Upper Arm Relative Prolongation Ability Score. Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9cc normal saline subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients.
Receives: Drug: Gadolinium
For Right Upper ArmExperimentalFor Right Upper Arm Total Persistent % subdermally, For Left Upper Arm Total Persistent % subcutaneously, and For Left Upper Arm Relative Prolongation Ability Score. Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9cc normal saline subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients.
Receives: Drug: Gadolinium
sPGA 50 n(%)ExperimentalsPGA 50 n(%) as Efficacy of Enbrel subcutaneously at Week 12, Efficacy of Enbrel subcutaneously at Week 24, and Efficacy of Enbrel subcutaneously at Week 36 vs. Efficacy of Enbrel subdermally at Week 12, Efficacy of Enbrel subdermally at Week 24, and Efficacy of Enbrel subdermally at Week 36. sPGA 50 n(%) "clear" or "minimal" is the % of patients who achieve a score of "clear" or "minimal" by the Static Physician Global Assessment (sPGA) and % of patients with a reduction of PASI of at least 50% from baseline.
Receives: Drug: Efficacy of Enbrel subcutaneously at Week 12; Drug: Efficacy of Enbrel subcutaneously at Week 24; Drug: Efficacy of Enbrel subcutaneously at Week 36; Drug: Efficacy of Enbrel subdermally at Week 12; Drug: Efficacy of Enbrel subdermally at Week 24; Drug: Efficacy of Enbrel subdermally at Week 36
PASI 75 n(%)ExperimentalPASI 75 n(%) Response to treatment defined as the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI, as PASI 75 n(%) subcutaneously at Week 12, PASI 75 n(%) subcutaneously at Week 24, and PASI 75 n(%) subcutaneously at Week 36 vs. PASI 75 n(%) subdermally at Week 12, PASI 75 n(%) subdermally at Week 24, and PASI 75 n(%) subdermally at Week 36.
Receives: Drug: PASI 75 n(%) subcutaneously at Week 12; Drug: PASI 75 n(%) subcutaneously at Week 24; Drug: PASI 75 n(%) subcutaneously at Week 36; Drug: PASI 75 n(%) subdermally at Week 12; Drug: PASI 75 n(%) subdermally at Week 24; Drug: PASI 75 n(%) subdermally at Week 36
Adverse Injection site reactionsExperimentalInjection site reactions as Adverse Reactions of Enbrel subcutaneously vs. Adverse Reactions of Enbrel subdermally at Week 36.
Receives: Drug: Adverse Reactions of Enbrel subcutaneously; Drug: Adverse Reactions of Enbrel subdermally at Week 36
Adverse Reactions with Heart failureExperimentalHeart failure as Adverse Reactions of Enbrel subcutaneously vs. Adverse Reactions of Enbrel subdermally at Week 36.
Receives: Drug: Adverse Reactions of Enbrel subcutaneously; Drug: Adverse Reactions of Enbrel subdermally at Week 36
Adverse Reactions Allergic ReactionsExperimentalAllergic Reactions as Adverse Reactions of Enbrel subcutaneously vs. Adverse Reactions of Enbrel subdermally at Week 36.
Receives: Drug: Adverse Reactions of Enbrel subcutaneously; Drug: Adverse Reactions of Enbrel subdermally at Week 36
Adverse Reactions Blood/low blood countsExperimentalBlood problems/low blood counts as Adverse Reactions of Enbrel subcutaneously vs. Adverse Reactions of Enbrel subdermally at Week 36.
Receives: Drug: Adverse Reactions of Enbrel subcutaneously; Drug: Adverse Reactions of Enbrel subdermally at Week 36
Adverse Reactions with Nervous systemExperimentalNervous system problems, such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes, as Adverse Reactions of Enbrel subcutaneously vs. Adverse Reactions of Enbrel subdermally at Week 36.
Receives: Drug: Adverse Reactions of Enbrel subcutaneously; Drug: Adverse Reactions of Enbrel subdermally at Week 36
Adverse Reactions with InfectionsExperimentalInfections (upper respiratory infection, pyelonephritis, bronchitis, septic osteomyelitis, wound infection, pneumonia, foot abscess, leg ulcer), as Adverse Reactions of Enbrel subcutaneously vs. Adverse Reactions of Enbrel subdermally at Week 36.
Receives: Drug: Adverse Reactions of Enbrel subcutaneously; Drug: Adverse Reactions of Enbrel subdermally at Week 36
Adverse Reactions with MalignanciesExperimentalMalignancies (lymphoma, basal \& squamous skin cancer, non-cutaneous solid tumor, \& Wegener's granulomatosis), as Adverse Reactions of Enbrel subcutaneously vs. Adverse Reactions of Enbrel subdermally at Week 36.
Receives: Drug: Adverse Reactions of Enbrel subcutaneously; Drug: Adverse Reactions of Enbrel subdermally at Week 36
Adverse Reactions with ImmunogenicityExperimentalImmunogenicity as Adverse Reactions of Enbrel subcutaneously vs. Adverse Reactions of Enbrel subdermally at Week 36.
Receives: Drug: Adverse Reactions of Enbrel subcutaneously; Drug: Adverse Reactions of Enbrel subdermally at Week 36
Adverse Reactions with AutoantibodiesExperimentalAutoantibodies, Lupus-like syndrome, autoimmune hepatitis, as Adverse Reactions of Enbrel subcutaneously vs. Adverse Reactions of Enbrel subdermally at Week 36.
Receives: Drug: Adverse Reactions of Enbrel subcutaneously; Drug: Adverse Reactions of Enbrel subdermally at Week 36

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relative Prolongation Ability Score for Gadolinium subdermally injected.

    Gadolinium will be injected with ASIS subdermally (30) or conventional subcutaneous (30) for 60 adult subjects with Plaque Psoriasis (involving at least 10% of body surface and a minimum Psoriasis Area \& Severity Index (PASI) score of 10), just for the particular plaque skin area. The first MRI taken promptly after Gadolinium injection for each patient would be his or her reference of 100% Persistent, to which his or her subsequent MRI taken @ 6 hr, @ 12 hr, and @24hr later will be compared for Persistent %.This approximation can only work if the variables are minimized to the same population with Plaque Psoriasis, and the particular plaque skin area. The Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % subcutaneously, Plaque Psoriasis will be very valuable indicators for us to modify the Enbrel dosage and duration for testing with that "unknown" subdermal bloodless space in Aim 2.

    Measured: 6 months

Secondary outcomes (1)

  1. Efficacy of Enbrel subcutaneously vs. subdermally in Plaque Psoriasis.

    Hypothetically, if that subdermal bloodless space in patients somehow failed to show prolongation of half-life for Gadolinium in Aim 1, we can still proceed with Aim 2, because Enbrel's Pharmacokinetics will be studied anyway, by following tumor necrosis factor, then comparing the Mean tumor necrosis factor receptor : Fc. However, the Pharmacokinetics of subdermally injected Enbrel will be just dependent on Enbrel's diffusion out of that subdermal bloodless space. Therefore, if Enbrel getting into the bloodstream becomes so severely inhibited, then we can just change the osmolality of Enbrel in the end. Response to treatment will be assessed after 3, 6 and 9 months of therapy, and defined as the patients who achieved a reduction in score of at least 75% from baseline by the PASI.8 Other therapeutic advantages of ASIS device subdermally over subcutaneously will also be studied by comparing the reduction of adverse reactions and injection site pain.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2014 (estimated)
  2. Study startJan 2016
  3. Primary completionJun 2016 (estimated)
  4. Study completionJun 2017 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02112097
Sponsor's protocol ID
NCTAR066986
Other IDs
R44AR066986
Acronym
ASISinPP
Status last verified
Jun 2015
First submitted
9 Apr 2014
Last updated
24 Jun 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Fisher CJ Jr, Agosti JM, Opal SM, Lowry SF, Balk RA, Sadoff JC, Abraham E, Schein RM, Benjamin E. Treatment of septic shock with the tumor necrosis factor receptor:Fc fusion protein. The Soluble TNF Receptor Sepsis Study Group. N Engl J Med. 1996 Jun 27;334(26):1697-702. doi: 10.1056/NEJM199606273342603.

    PubMed 8637514

  • Ware JE Jr, Gandek B. Overview of the SF-36 Health Survey and the International Quality of Life Assessment (IQOLA) Project. J Clin Epidemiol. 1998 Nov;51(11):903-12. doi: 10.1016/s0895-4356(98)00081-x.

    PubMed 9817107

  • Bhutani T, Wong JW, Bebo BF, Armstrong AW. Access to health care in patients with psoriasis and psoriatic arthritis: data from National Psoriasis Foundation survey panels. JAMA Dermatol. 2013 Jun;149(6):717-21. doi: 10.1001/jamadermatol.2013.133.

    PubMed 23783152

  • Paonessa DF, Goldstein JC. Anatomy and physiology of head and neck infections (with emphasis on the fascia of the face and neck). Otolaryngol Clin North Am. 1976 Oct;9(3):561-80. No abstract available.

    PubMed 980495

  • Ramey DR, Fries JF, Singh G. The Health Assessment Questionnaire 1995 - Status and Review. In: Spilker B, ed. "Quality of Life and Pharmacoeconomics in Clinical Trials." 2nd ed. Philadelphia, PA. Lippincott-Raven 1996;227

  • Enbrel (etanercept) Product Information http://pi.amgen.com/united_states/enbrel/derm/enbrel_pi

  • GAMMAGARD LIQUID Comparison of Intravenous and Subcutaneous Administration in Primary Immunodeficiency Diseases (PID). http://www.clinicaltrials.gov/ct2/show/NCT00546871?term=Gammagard+subcutaneous&rank=5

  • Magnevist (gadopentetate dimeglumine) Injection Product Information. http://bayerimaging.com/products/magnevist/safety-information_nsf.php

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Gadolinium, Efficacy of Enbrel subcutaneously at Week 12 and Efficacy of Enbrel subcutaneously at Week 24 in people with Plaque Psoriasis., run by ASIS Corporation at 2 sites 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 10 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Li Nguyen, MD ((714)-453-7857, dr.li.nguyen@asis-inc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative Prolongation Ability Score for Gadolinium subdermally injected. (time frame: 6 months). 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 NCT02112097, which also lists 8 linked publications.

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 24 Jun 2015.

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