Study of Efficacy, Safety of Fulranumab Monotherapy for OA of Hip or Knee, PAI3003

Janssen Research & Development, LLC41 enrolled

Overview

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of fulranumab as Monotherapy compared with placebo in participants with signs and symptoms of osteoarthritis of the hip or knee that are not adequately controlled by current pain therapy.

This is a randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-controlled (an inactive substance is given to one group of participants while active drug is given to another group of participants to see if there is a difference in response), parallel-group (study drugs given to participants in all treatment groups during the same time period) to evaluate the efficacy (capacity of the investigational drug to produce an effect), safety, and tolerability of fulranumab administered as monotherapy (alone; not in combination with other drug therapy) to participants with chronic moderate to severe pain and functional impairment from knee or hip osteoarthritis (OA) that is not adequately controlled by current pain therapy. The duration of participation in the study for an individual participant will be up to 67 weeks (includes a screening period of 3 weeks, a double-blind treatment period of 16 weeks, and a post-treatment follow-up period of up to 48 weeks).). All participants will be randomly assigned in a 1:1:1 ratio to 1 of 3 treatments (placebo, fulranumab 1mg, fulranumab 3mg) and given a single injection subcutaneously (under the skin) once every 4 weeks for up to 16 weeks. Blood samples will be collected from each participant at time points during the study. Safety evaluations will include assessment of adverse events, physical examinations, laboratory tests and vital signs which will be monitored throughout the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Osteoarthritis Pain

Interventions

PlaceboDRUG

Placebo will be administered once every 4 weeks for 16 weeks by subcutaneous (SC) injection (injection under the skin) into the thigh or abdomen.

Fulranumab 1 mgDRUG

Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.

Fulranumab 3 mgDRUG

Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of osteoarthritis (OA) of hip or knee based on criteria defined by the American College of Rheumatology and radiographic evidence of OA (Kellgren-Lawrence class ≥2) of the study joint * Scheduled joint replacement or planning to undergo a joint replacement surgery for the study joint * Must have an unsatisfactory response (inadequate efficacy or poor tolerability) that includes all 3 classes of analgesic medications (acetaminophen/paracetamol, NSAID, and an opioid); For participants in the USA and Canada: Must have an unsatisfactory response (inadequate efficacy or poor tolerability) that includes all 3 classes of analgesic medications (acetaminophen/paracetamol, NSAIDs, and opioids other than codeine or codeine combination products) * Moderate to severe pain and functional impairment based on the NRS, WOMAC pain and physical function subscales, and PGA * During treatment and within 24 weeks after the last injection of study drug: if female of childbearing potential, is not pregnant, breast-feeding, or planning to become pregnant, or if male, will not father a child Exclusion Criteria: * Increased risk of osteonecrosis (ON) or rapidly progressive osteoarthritis (RPOA) * Unstable or progressive neurologic disorders

Locations (28)

Unnamed facility

El Cajon, California, United States

Unnamed facility

Sherman Oaks, California, United States

Outcomes

Primary Outcomes

Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) pain subscale score

The WOMAC 3.1 is a multi-dimensional, osteoarthritis (OA) specific self-administered questionnaire using 24 questions with a 48-hour recall that are grouped into 3 subscales (pain, stiffness, and physical function) associated with hip or knee OA. Pain, stiffness, and physical function is rated on a scale of 0-10 (0 = less severe up to 10 = more severe).

Time frame: Baseline, Week 16

Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) physical function subscale score

See WOMAC 3.1 described above.

Time frame: Baseline, Week 16

Change from baseline to the end of Week 16 in Patient Global Assessment (PGA) score

The PGA is part of a comprehensive assessment of the impact of treatment for osteoarthritis that also includes pain and physical function. The PGA included in the present study indicates the perception of osteoarthritis in the study joint at the current time. Ratings are provided on an 11-point numerical rating scale from 0 ("Very Good") to 10 ("Very Bad").

Time frame: Baseline, Week 16

Secondary Outcomes

Change from baseline to the end of Week 16 in Patient Global Assessment (PGA) score

See PGA described above.

Time frame: Baseline, Week 16

Change from baseline to the end of Week 16 in WOMAC Stiffness subscale score

See WOMAC 3.1 described above.

Time frame: Baseline, Week 16

Change from baseline to the end of Week 16 in daily numerical rating scale (NRS) score

The numerical rating scale (NRS) uses an 11-point scale to assess OA pain ranging from 0 to 10 with high scores representing greater symptom severity (0=no pain and 10=pain as bad as you can imagine).

Data from ClinicalTrials.gov

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