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| ID | Type | Description | Link |
|---|---|---|---|
| 42160443PAI3003 | Other Identifier | Janssen Research & Development, LLC | |
| 2014-002598-13 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks) of placebo during the double-blind treatment phase. |
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| Fulranumab 1 mg | Experimental | Participants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks) of fulranumab 1 mg during the double-blind treatment phase. |
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| Fulranumab 3 mg | Experimental | Participants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks) of fulranumab 3 mg during the double-blind treatment phase. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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"). | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to the end of Week 16 in Patient Global Assessment (PGA) score | See PGA described above. | Baseline, Week 16 |
| Change from baseline to the end of Week 16 in WOMAC Stiffness subscale score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| El Cajon | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31387410 | Derived | 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. |
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| Fulranumab 1 mg | Drug | Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen. |
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| Fulranumab 3 mg | Drug | Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen. |
|
See WOMAC 3.1 described above.
| 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). | Baseline, Week 16 |
| Change from baseline to the end of Week 16 in Medical Outcomes Study (MOS) Sleep subscale scores | The MOS Sleep Scale (acute version) contains 12 items that address aspects of sleep. Six subscale scores may be calculated including: daytime somnolence, sleep disturbances, snoring, shortness of breath or headache upon awaking, adequacy of sleep and amount of sleep plus a summary index of sleep disturbances. A higher score indicates worse sleep in most domains, but the amount of sleep and adequacy of sleep are scored in the opposite direction.The primary subscale of interest in this study is daytime somnolence. | Baseline, Week 16 |
| Change from baseline to the end of Week 16 in Short-Form--36 (SF-36) subscale scores | The SF-36 is a self-administered, generic, 36-item questionnaire designed to cover 8 domains of functional health status and well-being, physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.Scoring yields 8 subscales based on the 8 domains covered in the questionnaire. These scales are scored from 0 to 100 with higher scores indicating better health. | Baseline, Week 16 |
| Change from baseline to the end of Week 16 in EuroQol, 5 dimensions, 5 levels (EQ-5D-5L) scale score | The EQ-5D is a self-administered, standardized measure of health status designed to provide a generic measure of health for clinical and economic appraisal that includes the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D 5 level (5L) version will be used in this study. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and unable or extreme problems. A unique health state is defined by combining 1 level from each of the 5 dimensions. | Baseline, Week 16 |
| Change from baseline to the end of Week 16 in the percentage of participants who are responders based on WOMAC pain and physical function subscale scores and PGA scale scores | Responders are defined as participants with percent improvement equal to and above the threshold values for WOMAC pain and physical function subscale scores and PGA scale scores, reported separately. | Baseline, Week 16 |
| Change from baseline to the end of Week 16 in the percentage of participants who are responders based on OMERACT-OARSI, MCII, and PASS scale scores | Responders are defined as participants with percent improvement equal to and above the threshold values for Outcome Measures in Rheumatology initiative/Osteoarthritis Research Society International (OMERACT-OARSI), Minimal Clinically Important Improvement (MCII), and the Patient Acceptable Symptom State (PASS) scale scores. | Baseline, Week 16 |
| Change from baseline to the end of Week 16 in the percentage of participants who use rescue medication and other osteoarthritis (OA) analgesia | Use of rescue medication (acetaminophen/paracetamol) and other OA pain medication will be recorded weekly during the study. | Baseline, Week 16 |
| Sherman Oaks |
| California |
| United States |
| Miami | Florida | United States |
| Traverse City | Michigan | United States |
| Omaha | Nebraska | United States |
| Cincinnati | Ohio | United States |
| San Antonio | Texas | United States |
| Leuven | Belgium |
| Newmarket | Ontario | Canada |
| Windsor | Ontario | Canada |
| Montreal | Quebec | Canada |
| Prague | Czechia |
| Uherské Hradiště | Czechia |
| Almere Stad | Netherlands |
| Bialystok | Poland |
| Gdynia | Poland |
| Poznan | Poland |
| Warsaw | Poland |
| Wroclaw | Poland |
| Zgierz | Poland |
| Alcalá de Henares | Spain |
| Barcelona | Spain |
| Madrid | Spain |
| Santiago de Compostela | Spain |
| Blackpool | United Kingdom |
| Cannock | United Kingdom |
| Mancheter | United Kingdom |
| Stourton | United Kingdom |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000592179 | fulranumab |
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