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Trial · Interventional

Status unknownPhase 4Registry data

Efficacy, Radiographic and Laboratory Changes in Refractory Rheumatoid Arthritis Patients Treated With H.P. Acthar Gel

NCTNCT03082573 (opens ClinicalTrials.gov in a new tab)Other idIS2017
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
30 participants (estimated)
Sponsor
Iraj Sabahi Research Inc. · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
3 Mar 2017
Primary completion
Feb 2018 (estimated)
Completion
Feb 2019 (estimated)
First posted
17 Mar 2017
Last update posted
17 Mar 2017
Conditions
Rheumatoid Arthritis

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2017201820192020
  1. Ph 4

    Efficacy, Radiographic and Laboratory Changes in Refractory Rheumatoid Arthritis Patients Treated With H.P. Acthar Gel

    NCT03082573

    3 Mar 2017 to est. Feb 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study will examine the clinical response, cytokine expression and joint imaging after addition of Acthar Gel. The hypothesis is that H.P. Acthar Gel is both safe and effective for treatment of patients with refractory rheumatoid arthritis (RA) and has different mechanism of action than steroids and other DMARDs.

Interventions

  • H.P. Acthar gelDrug

Arms2

  • Active comparator

    Group A

    Will be receiving the same background medications and H.P. Acthar gel 40 units twice weekly for 12 weeks. Patients in group A, can be cross over to group B on week 13 if disease is uncontrolled for continuation until week 24. If their disease is under control then they will continue with the same dosage until week 24. If the disease is under control, then tapering the steroid dosage can be attempted at the principal investigation's discretion.

  • Active comparator

    Group B

    Will be receiving the same background medications and H.P. Acthar gel 80 units twice weekly for 12 weeks. if the disease is not under control, will continue with same dosage until week 24. If the disease is under control, will be given the option to reduce the dosage to 40 units twice weekly only if patient is suffering from H.P. Acthar gel related adverse effects. If the disease is under control, then tapering the steroid dosage can be attempted at the principal investigation's discretion.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. ACR 20 response ACR 20 response

    Time frame · Baseline to week 12

    Registry description

    Equal or greater than 20 % reduction in RA disease activity

Secondary outcomes(9)

  1. ACR 50 response

    Time frame · Baseline to week 24

    Registry description

    Equal or greater than 50 % reduction in RA disease activity

  2. ACR 70 response

    Time frame · Baseline to week 24

    Registry description

    Equal or greater than 70 % reduction in RA disease activity

  3. EULAR moderate response

    Time frame · Baseline to week 24

    Registry description

    Decline in the DAS 28 score by \>1.2 (without reaching low disease activity) OR The decline of 0.6 to 1.2, plus reaching at least moderate disease activity (DAS28 \<5.1).

  4. EULAR good response

    Time frame · Baseline to week 24

    Registry description

    Decline in DAS 28 score must exceed 1.2 and result in the achievement of low disease activity (DAS28 \<3.2).

  5. Resolution of Powered Doppler Signal of MSKUS studies

    Time frame · Baseline to week 24

    Registry description

    Decline or resolution of synovitis detected in ultra sonographic examination of joints

  6. Resolution of signs of active inflammation in MRI

    Time frame · Baseline to week 24

    Registry description

    Decline or resolution of synovitis, tenosynovitis or bone edema detected in MRI examination of joints

  7. Reduction in Vectra DA Score

    Time frame · Baseline to week 24

    Registry description

    Decline in RA disease activity manifested as decline in Vectra DA Score

  8. Correlation between MSKUS and MRI Imaging findings

    Time frame · Baseline to week 24

    Registry description

    Comparison between MSKUS and MRI imaging

  9. Correlation between imaging findings and Vectra DA test

    Time frame · Baseline to week 24

    Registry description

    Comparison between MSKUS/MRI findings and Vectra DA test results

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Patients with diagnosis of RA with incomplete or failure to treatment described as either A or B A: Failure to achieve remission or low disease activity within 3 to 6 months of treatment with combination of methotrexate or other DMARDs therapy with a biologic DMARD in maximally tolerated doses within the usual therapeutic range. B- A requirement, in addition to DMARDs and biologic DMARDs, for chronic glucocorticoid therapy in a dose of greater than about 5 to 7.5 mg/day of prednisone or equivalent to achieve or maintain remission or low disease activity after 3 to 6 months of treatment. 2. Fluent in reading and writing in English language. 3. ≥ 21 years of age at the time of participation. Exclusion Criteria: 1. Pregnancy 2. Presence if contraindications for treatment with H.P. Acthar gel including but not limited to any known history of scleroderma, osteoporosis, systemic fungal infections, ocular Herpes Simplex, recent administration of live or live attenuated vaccine (prior 6 months), recent surgery (prior 6 months), history of or the presence of a peptic ulcer, primary adrenocortical insufficiency, adrenal cortical hyperfunction; congestive heart failure (defined as New York Hear Association Functional Class I to IV, uncontrolled hypertension. 3. Previous use of ACTH preparations for treatment of nephrotic syndrome (including but not limited to H.P. Acthar gel and Synacthen®). 4. Previous history of sensitivity to ACTH preparations (including but not limited to H.P. Acthar gel and Synacthen®). 5. Previous history of sensitivity to porcine protein products.

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