ACR Meeting Abstracts

ACR Meeting Abstracts

  • Meetings
    • ACR Convergence 2024
    • ACR Convergence 2023
    • 2023 ACR/ARP PRSYM
    • ACR Convergence 2022
    • ACR Convergence 2021
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • View and print all favorites
    • Clear all your favorites
  • ACR Meetings

Abstract Number: 0323

A Randomized, Double-blind, Placebo-controlled, Repeat Injection, 52-Week Study to Evaluate the Efficacy and Safety of an Intra-articular Injection (IAI) of CNTX-4975-05 (CNTX) in Subjects with Chronic, Moderate-to-severe Osteoarthritis Knee Pain (MSOAKP) – Study 304

James Connolly, James N Campbell, Randall Stevens and Colleen Newman, Centrexion Therapeutics Corporation, Boston, MA

Meeting: ACR Convergence 2023

Keywords: Osteoarthritis

  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print
Session Information

Date: Sunday, November 12, 2023

Title: (0308–0324) Osteoarthritis – Clinical Poster I

Session Type: Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: 30+ million US adults have OAKP. After years of using NSAIDs, analgesics, surgery and IAI, many patients remain with MSOAKP. CNTX is a 1 mg dose of capsaicin for IAI to reduce MSOAKP.

Methods: Efficacy and safety of a two IAI doses of placebo or 1 mg CNTX (Day 1 and at Week 26; ratio capsaicin/placebo 3:2; blinded randomization) were assessed in subjects with chronic, MSOAKP. Subjects were allowed specific MSOAKP concomitant and rescue medications during the study.

Pain was assessed using: a numeric pain rating scale (NPRS [0 – 10; 0 = no pain, 10 worst pain possible]). Subjects had Kellgren-Lawrence (KL) grades 2-4 (radiograph; 0=normal, 4=severe), and met knee OA (KOA) diagnostic criteria. Subjects were blindly randomized. The primary endpoint (Week 12) was the Western Ontario and McMaster Universities Osteoarthritis Index Subscale A (pain). Subjects were also assessed on WOMAC B (stiffness), WOMAC C (function), Numeric Pain Rating Scale (NPRS; 0-10), and Patient Global Impression of Change (PGIC; 0-7).

Key safety included physical exams, vital signs, ECGs, labs and bilateral fixed flexion knee radiographs at screening, and Week 52.

Results: 325 subjects received 1 dose of study drug (140 placebo, 184 CNTX); 243 randomized subjects completed out to Week 52; 89 subjects discontinued (DC) early. DC reasons were subject withdrawal (6.9%), lack of efficacy (6.3%) and other (5.1%). 15 (4.5%) subjects DC prior to Week 12. Mean age 62.8 years (range = 40-84), 61.4% female, 71.3% – not Hispanic or Latino; 70.4% Caucasian and 26.5% Back/African American.

Mean index knee baseline NPRS was 7.0, WOMAC A (0-50 scale; 0 = severe pain) 31.5; WOMAC B (0-20 scale) and WOMAC C (0-170) was 13.2 and 108.8, respectively.

Least-squares (LS) mean reduction was greater for CNTX than placebo (−16.20 vs -14.13, respectively; p = 0.0833). The WOMAC B / C, and NPRS were numerically better at nearly all visits through Week 26, and usually better to Week 52, for CNTX relative to placebo. Also, a greater proportion of CNTX subjects were considered PGIC responders at Week 12 and beyond – After the second IAI at Week 26, both pain and function improvements were seen in CNTX vs placebo, up to Week 52. (Table 1 and Figure 1).

There was more transient post injection pain on Day 1 in the CNTX group than placebo. Safety was acceptable out to Week 52 with knee radiographs showing no difference in KOA progression between placebo and CNTX, and no rapidly progressive osteoarthritis.

Conclusion: This study did not meet the primary endpoint. However, the numeric data suggested greater analgesic efficacy through Week 26 in CNTX compared to placebo. CNTX safety was acceptable. The NPRS difference was significant at several timepoints.

Supporting image 1

Supporting image 2


Disclosures: J. Connolly: Centrexion Therapeutics Corporation, 3; J. Campbell: None; R. Stevens: Centrexion Therapeutics Corporation, 3; C. Newman: Centrexion Therapeutics Corp, 3.

To cite this abstract in AMA style:

Connolly J, Campbell J, Stevens R, Newman C. A Randomized, Double-blind, Placebo-controlled, Repeat Injection, 52-Week Study to Evaluate the Efficacy and Safety of an Intra-articular Injection (IAI) of CNTX-4975-05 (CNTX) in Subjects with Chronic, Moderate-to-severe Osteoarthritis Knee Pain (MSOAKP) – Study 304 [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9). https://acrabstracts.org/abstract/a-randomized-double-blind-placebo-controlled-repeat-injection-52-week-study-to-evaluate-the-efficacy-and-safety-of-an-intra-articular-injection-iai-of-cntx-4975-05-cntx-in-subjects-with-chroni/. Accessed .
  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print

« Back to ACR Convergence 2023

ACR Meeting Abstracts - https://acrabstracts.org/abstract/a-randomized-double-blind-placebo-controlled-repeat-injection-52-week-study-to-evaluate-the-efficacy-and-safety-of-an-intra-articular-injection-iai-of-cntx-4975-05-cntx-in-subjects-with-chroni/

Advanced Search

Your Favorites

You can save and print a list of your favorite abstracts during your browser session by clicking the “Favorite” button at the bottom of any abstract. View your favorites »

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM ET on November 14, 2024. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].

Wiley

  • Online Journal
  • Privacy Policy
  • Permissions Policies
  • Cookie Preferences

© Copyright 2025 American College of Rheumatology