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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Repository Corticotropin Injection To Treat Rheumatoid Arthritis Patients Who Have Failed Three Biologic Therapies.

NCTNCT01966718 (opens ClinicalTrials.gov in a new tab)Other idATC 005
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
8 participants (actual)
Sponsor
Arthritis Treatment Center, Maryland · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Oct 2013
Primary completion
Oct 2015
Completion
Oct 2015
First posted
22 Oct 2013 (estimated)
Last update posted
18 Aug 2016 (estimated)
Conditions
Rheumatoid Arthritis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016
  1. Ph 4

    Repository Corticotropin Injection To Treat Rheumatoid Arthritis Patients Who Have Failed Three Biologic Therapies.

    NCT01966718

    Oct 2013 to Oct 2015

Registry summary

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

It is hypothesized that repository corticotropin injection in combination with other biologic agents will be able to provide relief of both rheumatoid arthritis and acute exacerbations of rheumatoid arthritis for patients with disease that had inadequately responded to biologics previously.

Interventions

  • Repository corticotropin injectionDrug

Arms1

  • Experimental

    Repository corticotropin injection

    Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change From Baseline in the Ritchey-Camp Articular Index

    Time frame · From baseline to week 16

    Registry description

    Change in the Number of Joints that had Tenderness and/or Swelling According to the Ritchey-Camp Articular Index. Change was calculated using baseline and week 16 time points.

  2. Change From Baseline in the 20-item Health Assessment Questionnaire Score

    Time frame · From baseline to week 16

    Registry description

    Subjects completed the Health Assessment Questionnaire, a 20-item scale that measures health-related quality of life. Participants are asked to rate activities on a scale from "able to do with no difficulties" to "unable to do". A score of 0 indicates the participant has no problems performing daily activities, while a score of 3 indicates that the participant is completely disabled. Scores were calculated by subtracting score at week 16 from baseline score. A positive number indicates the score went down from baseline to week 16.

Secondary outcomes(2)

  1. Change From Baseline in the Erythrocyte Sedimentation Rate (ESR)

    Time frame · From baseline to week 16

    Registry description

    ESR was measured at baseline at week 16. Change was measured by subtracting week 16 score from baseline score. A positive number indicates that the ESR decreased

  2. Change From Baseline in the C-Reactive Protein (CRP) Level

    Time frame · From baseline to week 16

    Registry description

    CRP was measured at Baseline and Week 16. Change was calculated by subtracting week 16 value from baseline value, with a positive value indicating a decrease from baseline.

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 outcomeMean· From baseline to week 16

Change From Baseline in the Ritchey-Camp Articular Index

GroupValue (joints)
Swollen Joints10.25
Tender Joints9
Primary outcomeMean· From baseline to week 16

Change From Baseline in the 20-item Health Assessment Questionnaire Score

GroupValue (units on a scale)
Repository Corticotropin Injection0.03
Secondary and other outcome results(2)
Secondary outcomeMean· From baseline to week 16

Change From Baseline in the Erythrocyte Sedimentation Rate (ESR)

GroupValue (mm/hr)
Repository Corticotropin Injection1.9
Secondary outcomeMean· From baseline to week 16

Change From Baseline in the C-Reactive Protein (CRP) Level

GroupValue (mg/dL)
Repository Corticotropin Injection0.19

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Repository Corticotropin InjectionRepository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances–1 / 86 / 8

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 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Rheumatoid arthritis of at least 2 years duration * On at least third biologic with a different mechanism of action for at least 12 weeks * Active disease as defined by at least 6 tender and 6 swollen joints * Erythrocyte sedimentation rate (ESR) at least 28 mm/hr or C-reactive protein (CRP) at least 1.2 times the upper limit of normal * Stable dose of disease modifying anti-rheumatic drug (DMARD) and prednisone for at least 4 weeks Exclusion Criteria: * Prior treatment with Acthar Gel * History of intolerance or allergy to glucocorticoids * Unstable diabetes * Active infection

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