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Rheumatoid ArthritisPhase 1NCT04559412

Study to Assess the Safety and Efficacy of Enbrel Administered by Sofusa DoseConnect for Rheumatoid Arthritis

A Phase 1 study testing Sofusa DoseConnect and Enbrel in people with Rheumatoid Arthritis, run by Sorrento Therapeutics, Inc. at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is an open-label pilot study in patients with rheumatoid arthritis (RA). All patients will receive SOFUSA Enbrel 25 mg once weekly. The dose will be increased to 50 mg if the dose escalation criteria are met during the dose escalation phase of the study. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Sofusa DoseConnect and Enbrel
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
15 Mar 2021to Dec 2024
Phase
Phase 1
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provides written informed consent
  • Has rheumatoid arthritis (RA) as defined by having a score of 6 or higher on the 2010 ACR-EULAR classification criteria
  • Is currently on Enbrel therapy and has received once-weekly Enbrel injections for at least 12 weeks with no more than 1 missed dose in the 12 weeks prior to Screening.
  • Must meet the following disease criteria:
  • Have a DAS28(CRP) score > 2.9 at Screening Have a DAS28(ESR) score > 3.2 at Screening Swollen joint count ≥ 3 (28-joint count) and Tender joint count ≥ 3 (28-joint count) at Screening and Baseline
  • If on oral or subcutaneous MTX (up to 25 mg/week) or other permitted oral conventional synthetic disease-modifying anti-rheumatic drugs (DMARDs) (i.e., leflunomide, up to 20 mg/day; hydroxychloroquine, up to 400 mg/day; or sulfasalazine, up to 3 g/day), must be on stable dose (MTX ≥ 12 weeks and other permitted DMARDs ≥ 8 weeks) within the specified ranges prior to Baseline. Note: if on methotrexate (MTX), subjects must be on a stable dose of folic acid (total ≥ 5 mg per week for ≥ 12 weeks) prior to Baseline and must continue a stable dose during the course of the study.
  • If taking regular nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 (COX-2) inhibitors, paracetamol/acetaminophen, or oral glucocorticoids for treatment of RA symptoms, must be on stable dose and route of administration for at least 2 weeks before Baseline
  • Females of childbearing potential must agree to use acceptable method(s) of contraception for the duration of the study and for 3 months after the last dose of study drug

Who cannot join

  • Has participated in a clinical trial with a drug or device within 30 days prior to Screening
  • Prior treatment with investigational therapy within 30 days or 5 half-lives before Screening (whichever is longer)
  • History of hypersensitivity to any recombinant protein drugs or any of the excipients used in Enbrel
  • Has skin contact sensitivities (due to SOFUSA device adhesive) or allergies to iodine (due to the iodine in ICG)
  • Lack of any clinical response to Enbrel in the Investigator's opinion
  • Treatment with other biologic agents (e.g., interleukin [IL] 6, IL17, IL12/23 inhibitors; abatacept, tumor necrosis factor [TNF] inhibitors) besides Enbrel within 24 weeks before Baseline
Show all 37Show fewer
  • Previous treatment with more than 2 other tumor necrosis factor (TNF) inhibitor therapies (besides Enbrel), more than 2 targeted therapies with different mechanisms of action (e.g., Janus kinase inhibitors, T cell costimulation inhibitor, IL-6 receptor antagonist), or any cell depleting agents (e.g., anti-CD20)
  • Use of chlorambucil or cyclophosphamide within 24 weeks of Baseline
  • Use of leflunomide within 8 weeks of Baseline, if washing out of leflunomide, unless a cholestyramine washout has been performed, then use of leflunomide within 4 weeks of Baseline
  • Use of MTX, hydroxychloroquine, or sulfasalazine within 4 weeks of Baseline, if washing out of MTX, hydroxychloroquine, or sulfasalazine
  • Any systemic nonbiologic DMARD (e.g., Janus kinase inhibitor, cyclosporine, azathioprine) within 4 weeks of Baseline
  • History of or ongoing inflammatory, autoimmune, or painful musculoskeletal diseases (except for Sjogren's syndrome or fibromyalgia) which could interfere with the RA assessments as determined by the Investigator
  • Functional RA status of class IV according to the ACR 1991 revised criteria at Screening or Baseline
  • Oral glucocorticoids > 10 mg/day prednisone equivalent within 4 weeks prior to Baseline
  • Opioid tolerant: defined as the use of opiate analgesics at a dose of > 30 mg/day of oral morphine equivalent on 4 of the last 7 days prior to Baseline
  • Use of intramuscular, intravenous, or intraarticular corticosteroid therapy within 4 weeks prior to Baseline
  • Treatment with any intra-articular hyaluronic acid preparation within 12 weeks prior to Baseline
  • Chronic arthritis diagnosis before the age of 17 years
  • Presence of any extra-articular manifestations of RA, except for rheumatoid nodules
  • Joint surgery within the preceding 8 weeks before Screening
  • History of, or presence of cancer (if < 5 years from successful treatment even with no evidence of recurrent disease) or lymphoproliferative or hematologic disease, other than a successfully and completely treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix and/or removed non-invasive colon or bladder polyps, with no evidence of recurrence
  • History of uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (New York Heart Association III-IV), active peptic ulcer disease, recent stroke, myocardial infarction, or thromboembolism (within 6 months), or any other condition which, in the opinion of the Investigator, would put the patient at risk by participation in the study
  • Previous diagnosis or signs of demyelinating disease
  • History of clinically significant hematologic (e.g. severe anemia, leukopenia, thrombocytopenia), renal or liver disease (e.g. glomerulonephritis, fibrosis, cirrhosis, hepatitis) or abnormal clinical laboratory tests at Screening
  • Receipt of any blood products within 12 weeks of Baseline
  • History of persistent chronic infection; recurrent infection (more than 3 infections requiring antimicrobial therapy within the last 12 months); or active infections requiring hospitalization or treatment with systemic anti-infective therapy within 4 weeks before Screening (counted from anti-infective therapy stop date), except for fungal infection of nails or nail beds
  • History of or current active tuberculosis or presence of latent tuberculosis as detected by imaging (e.g., chest radiograph) and/ or QuantiFERON®-TB Gold Plus test (QFT) NOTE: Positive QFT (or 2 or more tests that are indeterminate) and/or positive imaging result (within 12 weeks prior to Screening or at Screening) excludes a patient from participation in the study (except for patients who have documentation of completing an acceptable regimen for treatment of latent tuberculosis with no known re-exposure to tuberculosis since treatment completion)
  • History or evidence of opportunistic infections (eg, histoplasmosis, listeriosis, legionellosis)
  • Known immune deficiency, known human immunodeficiency virus (HIV) positive or positive at Screening, or immunocompromised for other reasons
  • Serology positive for hepatitis B virus (HBV) surface antigen (HBsAg) or core antibody (HBcAb) or hepatitis C virus (HCV) antibody (HCV-Ab) or ribonucleic acid (HCV RNA). Patients treated for HCV and considered cured (negative HCV RNA) may participate in the study
  • Positive RT-PCR or the equivalent COVID-19 test at Screening
  • History or evidence of ongoing significant drug or alcohol abuse
  • Known depression or other psychiatric condition, which in the Investigator's opinion may decrease likelihood of participant adherence to the study protocol requirements
  • History of vaccination with live vaccines within the preceding 8 weeks prior to Baseline or known to require vaccination with live vaccines during the study period
  • For female participants, currently breastfeeding (lactating) or less than 12 weeks from cessation of lactation
  • Pregnant woman where pregnancy is defined as the state of a woman after conception and until the termination of gestation, confirmed by a positive serum pregnancy test at Screening or positive urine pregnancy test at Baseline
  • Patient is considered by the Investigator, for any reason, to be an unsuitable candidate for the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Atlanta Research Center for Rheumatology

    Atlanta, Georgia, 30060

Other trials in United States

About this study

Official title: Phase 1b Proof-of-concept, Open-label Study to Assess the Safety and Pilot Efficacy of Enbrel® Administered by the Sofusa® DoseConnect™ Delivery System for the Treatment of Rheumatoid Arthritis

This is an open-label pilot study in patients with rheumatoid arthritis (RA). All patients will receive SOFUSA Enbrel 25 mg once weekly. The dose will be increased to 50 mg if the dose escalation criteria are met during the dose escalation phase of the study.

Read the detailed description

This study is a Phase 1b proof-of-concept, open-label study to assess the safety and pilot efficacy of Enbrel administered by the Sofusa® DoseConnect™ delivery system (SOFUSA) for the treatment of patients with moderately to severe RA and an inadequate response to subcutaneous (SC) Enbrel. SOFUSA Enbrel will be administered once weekly to patients for 12 weeks. Patients will start on an Enbrel dose of 25 mg during the induction phase of the study and may be increased to an Enbrel dose of 50 mg during the dose escalation phase of the study based on the dose escalation criteria. Patients will remain on either the 25 mg or 50 mg dose for the final maintenance phase of the study.

Being tested
Sofusa DoseConnect, Enbrel
Keywords
rheumatoid arthritis
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • Sofusa DoseConnectDevice

    Also called sofusa

    25 to 50 mg Enbrel® administered by the Sofusa® DoseConnect™ delivery system once weekly for 12 weeks

  • EnbrelDrug

    25 to 50 mg Enbrel® administered by the Sofusa® DoseConnect™ delivery system once weekly for 12 weeks

Study groups in NCT04559412
Study groupRoleWhat they receive
Sofusa EnbrelExperimentalEnbrel® administered by the Sofusa® DoseConnect™ delivery system
Receives: Device: Sofusa DoseConnect; Drug: Enbrel

What is being measured

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

  1. Incidence and severity of adverse events and their relationships to SOFUSA administration

    Incidence and severity of adverse events and their relationships to SOFUSA administration

    Measured: Baseline through Week 12

Secondary outcomes (12)

  1. Change in Disease Activity Score 28-joint count C reactive protein (DAS28(CRP))

    Change from Baseline in DAS28(CRP) score at Week 12

    Measured: Baseline to Week 12

  2. Change in DAS28(CRP) score over time

    Change from Baseline in DAS28(CRP) score over time

    Measured: Baseline through Week 12

  3. Change in Disease Activity Score 28-joint count erythrocyte sedimentation rate (DAS28(ESR)) over time

    Change from Baseline in DAS28(ESR) score over time

    Measured: Baseline through Week 12

  4. Change in Simplified Disease Activity Index (SDAI) score over time

    Change from Baseline in SDAI score over time

    Measured: Baseline through Week 12

  5. Change in Clinical Disease Activity Index (CDAI) score over time

    Change from Baseline in CDAI score over time

    Measured: Baseline through Week 12

  6. Proportion of patients with low disease activity (LDA) over time as assessed by the DAS28(CRP)

    Proportion of patients with DAS28(CRP) score < 2.9 over time

    Measured: Baseline through Week 12

  7. Proportion of patients with LDA over time as assessed by the DAS28(ESR)

    Proportion of patients with DAS28(ESR) score ≤ 3.2 over time

    Measured: Baseline through Week 12

  8. Proportion of patients with LDA over time as assessed by the SDAI

    Proportion of patients with SDAI score ≤ 11.0 over time

    Measured: Baseline through Week 12

  9. Proportion of patients with LDA over time as assessed by the CDAI

    Proportion of patients with CDAI score ≤ 10 over time

    Measured: Baseline through Week 12

  10. Proportion of patients achieving ACR20/50/70 response over time

    Proportion of patients achieving ACR20/50/70 response over time

    Measured: Baseline through Week 12

  11. Proportion of patients achieving moderate or good EULAR response over time

    Proportion of patients achieving moderate or good EULAR response over time

    Measured: Baseline through Week 12

  12. Proportion of patients achieving a minimally clinically important difference (MCID) of 0.22 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) over time

    Proportion of patients achieving a MCID of 0.22 in HAQ-DI over time

    Measured: Baseline through Week 12

Timeline

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

  1. First posted22 Sep 2020
  2. Study start15 Mar 2021
  3. Primary completionJan 2024 (estimated)
  4. Study completionDec 2024 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04559412
Sponsor's protocol ID
STI-SOFUSA-1003
Status last verified
Apr 2023
First submitted
3 Sep 2020
Last updated
12 Apr 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sofusa DoseConnect and Enbrel in people with Rheumatoid Arthritis, run by Sorrento Therapeutics, 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 8 inclusion and 37 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 12 Apr 2023. 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. 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 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.

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?

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?

Incidence and severity of adverse events and their relationships to SOFUSA administration (time frame: Baseline through Week 12). 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 NCT04559412.

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 12 Apr 2023.

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