Study of Safety, Efficacy of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3007

NCT ID: NCT02301234

Last Updated: 2017-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-25
• Study Completion Date: 2016-09-19

Brief Summary

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of fulranumab as adjunctive therapy 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.

Detailed Description

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 adjunctive therapy (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. In addition, participants may elect to receive adjunctive therapy (ie, double-blind supplemental oral analgesic medication or matching placebo) throughout the double-blind treatment period. 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.

Conditions

Osteoarthritis; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Participants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks) of placebo during the double-blind treatment phase. In addition, participants may take adjunctive therapy with celecoxib 100 mg orally (by mouth) twice daily for up to 16 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered once every 4 weeks with or without adjunctive therapy for 16 weeks by subcutaneous (SC) injection (injection under the skin) into the thigh or abdomen.

Celecoxib 100 mg

Intervention Type: DRUG

Double-blind capsules taken twice daily for up to 16 weeks.

Fulranumab 1 mg

Participants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks) of fulranumab 1 mg during the double-blind treatment phase. In addition, participants may take adjunctive therapy with celecoxib placebo orally twice daily for up to 16 weeks.

Group Type: EXPERIMENTAL

Fulranumab 1 mg

Intervention Type: DRUG

Fulranumab will be administered once every 4 weeks with or without adjunctive therapy for up to 16 weeks by SC injection into the thigh or abdomen.

Celecoxib 100 mg Matching Placebo

Intervention Type: DRUG

Double-blind capsules taken twice daily for up to 16 weeks.

Fulranumab 3 mg

Participants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks) of fulranumab 3 mg during the double-blind treatment phase. In addition, participants may take adjunctive therapy with celecoxib placebo orally twice daily for up to 16 weeks.

Group Type: EXPERIMENTAL

Fulranumab 3 mg

Intervention Type: DRUG

Fulranumab will be administered once every 4 weeks with or without adjunctive therapy for up to 16 weeks by SC injection into the thigh or abdomen.

Celecoxib 100 mg Matching Placebo

Intervention Type: DRUG

Double-blind capsules taken twice daily for up to 16 weeks.

Interventions

Placebo

Placebo will be administered once every 4 weeks with or without adjunctive therapy for 16 weeks by subcutaneous (SC) injection (injection under the skin) into the thigh or abdomen.

Intervention Type: DRUG

Fulranumab 1 mg

Fulranumab will be administered once every 4 weeks with or without adjunctive therapy for up to 16 weeks by SC injection into the thigh or abdomen.

Intervention Type: DRUG

Fulranumab 3 mg

Fulranumab will be administered once every 4 weeks with or without adjunctive therapy for up to 16 weeks by SC injection into the thigh or abdomen.

Intervention Type: DRUG

Celecoxib 100 mg

Double-blind capsules taken twice daily for up to 16 weeks.

Intervention Type: DRUG

Celecoxib 100 mg Matching Placebo

Double-blind capsules taken twice daily for up to 16 weeks.

Intervention Type: DRUG

Eligibility Criteria

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
• Unsatisfactory response (inadequate efficacy or poor tolerability) on local standard of care that includes 3 medications from at least 2 of the following classes of analgesic medications (acetaminophen/paracetamol, NSAIDs, or opioid). For participants in the USA and Canada only: 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Glendale, Arizona, United States

Phoenix, Arizona, United States

Tucson, Arizona, United States

Little Rock, Arkansas, United States

Anaheim, California, United States

Garden Grove, California, United States

Los Angeles, California, United States

North Hollywood, California, United States

Boulder, Colorado, United States

Coral Gables, Florida, United States

Miami, Florida, United States

Orlando, Florida, United States

Winter Park, Florida, United States

Columbus, Georgia, United States

Chicago, Illinois, United States

Overland Park, Kansas, United States

Elkridge, Maryland, United States

Detroit, Michigan, United States

St Louis, Missouri, United States

Brooklyn, New York, United States

New York, New York, United States

Norman, Oklahoma, United States

Knoxville, Tennessee, United States

Memphis, Tennessee, United States

Tullahoma, Tennessee, United States

Arlington, Texas, United States

Houston, Texas, United States

Lampasas, Texas, United States

Nassau Bay, Texas, United States

Sugar Land, Texas, United States

Arlington, Virginia, United States

Charlottesville, Virginia, United States

Camperdown, , Australia

Hobart, , Australia

Kippa-Ring, , Australia

Kogarah, , Australia

Maroochydore, , Australia

Melbourne, , Australia

Sherwood, , Australia

Kamloops, British Columbia, Canada

Kelowna, British Columbia, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

West Vancouver, , Canada

Prague, , Czechia

Leipzig, , Germany

Szekszárd, , Hungary

Elblag, , Poland

Katowice, , Poland

Krakow, , Poland

Torun, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Anyang, , South Korea

Jeju City, , South Korea

Seoul, , South Korea

A Coruña, , Spain

Santiago de Compostela, , Spain

Lund, , Sweden

Malmo, , Sweden

Blackpool, , United Kingdom

Cannock, , United Kingdom

Mancheter, , United Kingdom

Stourton, , United Kingdom

Countries

United States; Australia; Canada; Czechia; Germany; Hungary; Poland; South Korea; Spain; Sweden; United Kingdom

References

Kelly KM, Sanga P, Zaki N, Wang S, Haeussler J, Louie J, Thipphawong J. Safety and efficacy of fulranumab in osteoarthritis of the hip and knee: results from four early terminated phase III randomized studies. Curr Med Res Opin. 2019 Dec;35(12):2117-2127. doi: 10.1080/03007995.2019.1653068. Epub 2019 Sep 13.

Reference Type: DERIVED

PMID: 31387410 (View on PubMed)

Other Identifiers

42160443PAI3007

Identifier Type: OTHER

Identifier Source: secondary_id

2014-003224-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR106249

Identifier Type: -

Identifier Source: org_study_id