Purified Cortrophin® Gel Efficacy and Safety Study of 2 Dose Levels in Patients With Acute Gout Flares
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-90
SponsorMassachusetts General Hospital
About this trial
This is a randomized, multicenter, double-blind, single administration study to investigate the efficacy and safety of 2 dosing regimens of Purified Cortrophin® Gel in the treatment of an acute gouty arthritis flare.
The study consists of three periods: an optional pre-screening period, a double-blind treatment period, and a 7-day follow-up period.
The treatment period is double-blind, and the patients will be randomized to treatment with 40 U Purified Cortrophin® Gel or 80 U Purified Cortrophin® Gel in a 1:1 ratio. Purified Cortrophin® Gel will be administered once (either subcutaneously or intramuscularly) on the first visit (Day 0; Visit 1) and surveyed after 24 hours (Day 1), 48 hours (Day 2), and 72 hours (Day 3; Visit 2) as well as on Day 7.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent to participate in this study
Male and female patients, aged 18-85 years
Meeting the 2015 Gout classification criteria of the ACR/EULAR collaborative initiative
Onset of current acute gout flare within 5 days prior to study entry
Disqualifiers
Patients with scleroderma, osteoporosis, active or recurrent bacterial, fungal or viral infections, ocular herpes simplex, recent surgery (within 2 weeks prior to randomization or have an unhealed operation wound(s)), history of or the presence of a peptic ulcer, uncontrolled congestive heart failure, uncontrolled hypertension, uncontrolled diabetes type 1 or 2, or sensitivity to proteins derived from porcine sources.
Patients with primary adrenocortical insufficiency or adrenocortical hyperfunction.
Rheumatoid arthritis, evidence or suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
Polyarticular gouty arthritis involving more than 4 joints.
Trial design
Design model
Parallel
Treatments tested in this trial
Purified Cortophin Gel, 40 U
DrugThis will be the 40 U dose of the purified Cortophin Gel
Purified Cortophin Gel 80 U
DrugThis will be the 80 U dose of the purified Cortophin Gel
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Purified Cortophin Gel 40 UExperimental treatment 1 intervention
Group B: Purified Cortophin Gel 80 UExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in gout pain intensity from baseline in target join to 72 hours post-injection
Change in gout pain intensity from baseline in the target joint following PCG administration measured by Visual Analog Scale (VAS) at 72 hours post-injection (Day 3; Visit 2). Patients will score their pain intensity in the joint most affected at baseline (i.e., the index joint) on a 0-100 mm visual analogue scale (VAS), ranging from no pain (0) to unbearable pain (100).
Time frame
From baseline to Day 3/Visit 2Secondary outcomes
1
Change in gout pain from baseline in target joint at Day 1
Change in gout pain intensity from baseline in the target joint following Purified Cortrophin® Gel administration measured by Visual Analog Scale (VAS) at Day 1 (24 hours post-injection). Minimum value: 0 Maximum value: 10 Higher score indicates worse outcome.
Time frame
From baseline to Day 12
Change in gout pain intensity from baseline in target joint to Day 2
Change in gout pain intensity from baseline in the target joint following Purified Cortrophin® Gel administration as measured by Visual Analog Scale (VAS) at Day 2 (48 hours post-injection). Minimum value: 0 Maximum value: 10 Higher score indicates worse outcome.
Time frame
From baseline to Day 23
Change in pain intensity timeline at baseline, 24 hours, 48 hours, 72 hours, and Day 7 post-injection.
Change in pain intensity timeline at baseline, 24 hours, 48 hours, 72 hours, and Day 7 post-injection.
Time frame
From baseline to Day 74
Time to onset of effect (≥20% change from baseline pain intensity on VAS).
Time to onset of effect (≥20% change from baseline pain intensity on VAS).
Time frame
From baseline to end of study (Day 7)Other outcomes
1
Levels of inflammatory markers (baseline [Day 0; Visit 1], 72 hours [Day 3; Visit 2])
Levels of inflammatory markers (baseline \[Day 0; Visit 1\], 72 hours \[Day 3; Visit 2\]) * C-reactive protein * Serum amyloid A
Time frame
From baseline to Day 3/Visit 22
Change from baseline in health-related quality-of-life Gout Attack Intensity Score (GAIS) at Day 0 (Visit 1) and at Day 3 (72-hours post-injection; Visit 2) (19).
Change from baseline in health-related quality-of-life Gout Attack Intensity Score (GAIS) at Day 0 (Visit 1) and at Day 3 (72-hours post-injection; Visit 2) (19). 1. How much pain is your gout causing you today? (color in one box completely) * 1 No pain * 2 Mild pain * 3 Moderate pain * 4 A lot of pain * 5 Extreme pain 2. How tender to the touch are the gout-affected parts of your body today? (colour in one box completely) * 1 Not tender * 2 Slightly tender * 3 Fairly tender * 4 Very tender * 5 Extremely tender 3. How swollen are the gout-affected parts of your body today? (colour in one box completely) * 1 Not swollen * 2 Somewhat swollen * 3 Fairly swollen * 4 Very swollen * 5 Extremely swollen The answers across all three questions will be totaled, with higher scores indicating worse outcomes. Minimum value: 3, maximum value: 15
Time frame
From baseline to Day 3/Visit 2Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
ANI Pharmaceuticals
Collaborator
Source ClinicalTrials.gov