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Trial · Interventional

CompletedNot applicableResults postedRegistry data

ACTH Gel Therapy in Rheumatoid Arthritis

NCTNCT02030028 (opens ClinicalTrials.gov in a new tab)Other idSTUDY19050342
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
18 participants (actual)
Sponsor
Dana Ascherman · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Nov 2014
Primary completion
30 Jun 2022
Completion
30 Jun 2022
First posted
8 Jan 2014 (estimated)
Last update posted
6 Sept 2023
Conditions
Rheumatoid Arthritis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142016201820202022
  1. N/A

    ACTH Gel Therapy in Rheumatoid Arthritis

    NCT02030028

    Nov 2014 to 30 Jun 2022

Registry summary

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

The purpose of this research study is to evaluate if the study drug, ACTH Gel helps decrease the disease symptoms in people with Rheumatoid Arthritis (RA) who are already taking medications prescribed by their physician and are still experiencing disease symptoms. ACTH gel has been a Food and Drug Administration-approved treatment for Rheumatoid Arthritis since 1952, and in 2010 the FDA retained RA as a disease approved for ACTH gel use. Despite its FDA approval there is very limited data on its how well ACTH gel works in improving the symptoms of people with RA.

Interventions

  • ACTHAR gelDrug

Arms1

  • Other

    ACTHAR Gel

    Open label Adrenocorticotropic Hormone (ACTH) Gel for 12 weeks, 80u (1mL), given subcutaneously twice each week.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12

    Time frame · 12 weeks

    Registry description

    percentage of participants achieving \>20% improvement in CDAI after 12 weeks of therapy (\>20% reduction in CDAI relative to baseline based on ratio of CDAI at week 12 to CDAI at week 0: CDAI Week 12/CDAI Week 0 \< 0.8 meets criteria for improvement, as lower CDAI scores represent lower disease activity)

Secondary outcomes(4)

  1. Change in the Disease Activity Score (DAS28-CRP) Between Week 0 and Week 12

    Time frame · 12 weeks

    Registry description

    Change in the Disease Activity Score 28-CRP (DAS28-CRP) at week 12 relative to baseline (week 0), where lower DAS28-CRP scores at week 12 represent improvement. Scale: 0-8.61 (lower scores indicate reduced disease activity)

  2. Changes in Acute Phase Reactants (CRP) Between Week 0 and Week 12

    Time frame · 12 weeks

    Registry description

    Changes in C-reactive protein value (mg/dl): reduction in CRP values at week 12 relative to week 0 represents improvement (week 12 CRP-baseline CRP \< 0))

  3. Change in Acute Phase Reactants (ESR) Between Week 0 and Week 12

    Time frame · 12 weeks

    Registry description

    Change in ESR--reduction in ESR at week 12 relative to baseline (week 0) represents improvement (week 12 ESR - baseline ERS \< 0)

  4. Patient Reported Changes in Fatigue Between Week 0 and Week 12

    Time frame · 12 weeks

    Registry description

    The FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) scoring metric assesses fatigue using 13 questions rated on a Likert scale of 0 (no fatigue)-4 (severe fatigue); total scores range from 0-52, with higher total scores representing more severe fatigue. The difference in FACIT-F scores between weeks 12 and week 0 (calculated as FACIT-F score week 12 minus FACIT-F score at week 0) indicates changes in fatigue relative to baseline, where reduction of FACIT-F score at week 12 represents improvement in fatigue.

Posted results

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

Primary outcome results

Primary outcomeCount of participants· 12 weeks

Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12

GroupValue (Participants)
ACTHAR Gel8
Secondary and other outcome results(4)
Secondary outcomeMean· 12 weeks

Change in the Disease Activity Score (DAS28-CRP) Between Week 0 and Week 12

GroupValue (units on a scale)Spread
ACTHAR Gel-0.871.75
Secondary outcomeMean· 12 weeks

Changes in Acute Phase Reactants (CRP) Between Week 0 and Week 12

GroupValue (mg/dl)Spread
ACTHAR Gel0.361.33
Secondary outcomeMean· 12 weeks

Change in Acute Phase Reactants (ESR) Between Week 0 and Week 12

GroupValue (mm/hr)Spread
ACTHAR Gel-7.3828.30
Secondary outcomeMedian· 12 weeks

Patient Reported Changes in Fatigue Between Week 0 and Week 12

GroupValue (units on a scale)
ACTHAR Gel-3.8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
ACTHAR GelOpen label Adrenocorticotropic Hormone (ACTH) Gel for 12 weeks, 80u (1mL), given subcutaneously twice each week. ACTHAR gel: Subjects are given the ACTHAR gel subcutaneously twice per week for 12 weeks.0 / 180 / 181 / 18

Each cell reads participants affected / participants at risk, as the registry posted them.

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 18 Years up to 100 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 18 year of age and older * RA diagnosis by American College of Rheumatology criteria * Active disease (CDAI \> 10) * Have received at least are biologic agent for at least 6 months * May or may not be receiving oral daily steroids (less than or equal to 20 mg/day) of prednisone equivalent * No current active infections requiring antibiotics * Patients must be on stable doses of RA therapies (e.g., methotrexate or other RA therapies for at least 4 weeks prior to baseline visit) Exclusion Criteria: * Less than 18 years of age * Unable or unwilling to give Informed Consent * Have an active infection requiring the use of antibiotics * Women who are pregnant * Uncontrolled hypertension * Abnormal renal function * Abnormal liver function as defined by and increased Alanine transaminase (ALT,) and aspartate aminotransferase (AST) that is greater than 5 times normal.

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