Safety & Efffficacy of Genakumab in Patients With Frequent Flares

Changchun GeneScience Pharmaceutical Co., Ltd.313 enrolled

Overview

The purpose of this study is to evaluate the efficacy and safety of Genakumab Injection in patients with Gouty Arthritis (GA).

A multicenter, randomized, double-blind, double-dummy, active-controlled study was to demonstrate the efficacy of Genakumab versus compound betamethasone injection in adult patients with frequent gouty arthritis attacks in whom non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine are contraindicated, are not tolerated, or do not provide an adequate response.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

313

Conditions

Acute Gout Arthritis

Interventions

genakumabDRUG

200mg s.c.

placebo for DiprospanDRUG

i.m.

placebo for genakumabDRUG

s.c.

Diprospan

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female, 18 years ≤ age ≤75 years * BMI≤40kg/m2 * Meeting ACR 2015 preliminary criteria for the classification of acute arthritis of primary gout. * Start of acute gout flare within 4 days prior to enrolled * History of ≥ 2 gout flares within the 12 months prior to study start * Evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy for either NSAIDs and/or colchicines * Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (VAS) Exclusion Criteria: \-

Locations (1)

Fudan University Affiliated Huashan Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

The change in the gout pain intensity in the target joint measured by VAS

The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. In this study patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0mm) to unbearable pain (100mm), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left.

Time frame: 72 hours post-dose

Time to first new flare

Time frame: 12 weeks

Secondary Outcomes

Patients assessment of gout pain intensity in the target joints measured by VAS(0-100mm)

Time frame: At 6, 24, 48, and 72 hours and 7 days post-dose

The change in the gout pain intensity in the target joint measured by VAS.

Time frame: At 6, 24, 48, and 72 hours and 7 days post-dose

The number of patients with at least 1 new gout flare

Time frame: 12 weeks, 24 weeks, 48 weeks

Time to at Least a 50% Reduction in Baseline Pain Intensity

Time frame: 7 days

Percent Patients Who Took Rescue Medication

Time frame: 24 weeks,48 weeks

Time to first flare

Time frame: 24 weeks, 48 weeks

Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame: 24weeks, 48weeks

Data from ClinicalTrials.gov

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