Study of Efficacy, Safety of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3001

NCT ID: NCT02336685

Last Updated: 2017-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-07
• Study Completion Date: 2016-09-16

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 chronic moderate to severe pain and functional impairment from knee or hip osteoarthritis that is 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. All participants will be allowed standard of care for OA pain during the double-blind treatment phase and must be taking an opioid at study entry and during the double-blind treatment phase. 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 to opioids as standard of care.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Opioid

Intervention Type: DRUG

Opioids will be administered as standard of care for osteoarthritis (OA) pain therapy during the double-blind treatment phase as per investigator discretion.

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 to opioids as standard of care.

Group Type: EXPERIMENTAL

Fulranumab 1 mg

Intervention Type: DRUG

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

Opioid

Intervention Type: DRUG

Opioids will be administered as standard of care for osteoarthritis (OA) pain therapy during the double-blind treatment phase as per investigator discretion.

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 to opioids as standard of care.

Group Type: EXPERIMENTAL

Fulranumab 3 mg

Intervention Type: DRUG

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

Opioid

Intervention Type: DRUG

Opioids will be administered as standard of care for osteoarthritis (OA) pain therapy during the double-blind treatment phase as per investigator discretion.

Interventions

Placebo

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

Intervention Type: DRUG

Opioid

Opioids will be administered as standard of care for osteoarthritis (OA) pain therapy during the double-blind treatment phase as per investigator discretion.

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
• An unsatisfactory response (inadequate efficacy or poor tolerability) that includes all 3 classes of analgesic medications (acetaminophen/paracetamol, NSAIDs, and opioids) and receiving an opioid at study entry; For participants in the USA and Canada: 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) and receiving an opioid (other than codeine or codeine combination products) at study entry
• 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

Birmingham, Alabama, United States

Huntsville, Alabama, United States

Cerritos, California, United States

Denver, Colorado, United States

Stamford, Connecticut, United States

Lewes, Delaware, United States

Newark, Delaware, United States

Crystal River, Florida, United States

Fort Lauderdale, Florida, United States

Hialeah, Florida, United States

Opa-locka, Florida, United States

Port Orange, Florida, United States

Marietta, Georgia, United States

Woodstock, Georgia, United States

Chicago, Illinois, United States

Rockford, Illinois, United States

Prairie Village, Kansas, United States

Lake Charles, Louisiana, United States

New Orleans, Louisiana, United States

Frederick, Maryland, United States

Worcester, Massachusetts, United States

Las Vegas, Nevada, United States

Albuquerque, New Mexico, United States

Brooklyn, New York, United States

Lake Success, New York, United States

Oklahoma City, Oklahoma, United States

Downingtown, Pennsylvania, United States

Duncansville, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Wyomissing, Pennsylvania, United States

Jackson, Tennessee, United States

Austin, Texas, United States

Dallas, Texas, United States

Houston, Texas, United States

West Jordan, Utah, United States

Richmond, Virginia, United States

Burlington, Ontario, Canada

Sarnia, Ontario, Canada

Baja, , Hungary

Szeged, , Hungary

Canterbury, , New Zealand

Newtown, , New Zealand

Takapuna, , New Zealand

Tauranga, , New Zealand

Bialystok, , Poland

Gdansk, , Poland

Myślenice, , Poland

Blackpool, , United Kingdom

Cannock, , United Kingdom

Greater Manchester, , United Kingdom

Mancheter, , United Kingdom

Matrix Park Buckshow Willage, , United Kingdom

Stourton, , United Kingdom

Countries

United States; Canada; Hungary; New Zealand; Poland; 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

42160443PAI3001

Identifier Type: OTHER

Identifier Source: secondary_id

2013-001830-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR100068

Identifier Type: -

Identifier Source: org_study_id