Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RN624 (PF-04383119), tanezumab
RN624 · 15 trials · 15 indications
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
PGA of OA was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.
Daily average pain intensity in the index bone metastasis cancer pain site was assessed by participants on an 11 point pain intensity NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores signified more severity of pain. The participants recorded their daily average pain at the painful site during the past 24 hours by choosing the appropriate number from 0 to 10 on interactive response technology (IRT) diaries. Baseline daily average pain intensity value was mean of the daily average pain intensity NRS scores during the baseline assessment period prior to randomization. Baseline assessment period was up to 5 days prior to dosing. The Week 8 daily average pain intensity value was the mean of the daily average pain intensity NRS scores recorded for each of the 7 days prior to the Week 8.
Average low back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive response technology (IRT). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function.
PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition.
Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition.
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. Overall possible score range for daily average LBPI at specified visit was 0= no pain to 10= worst possible pain, where higher scores indicated higher pain intensity.
Daily average pain was assessed on an 11-point NRS over the past 24 hours (before each specified visit), where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Lower the score, lesser the pain intensity.
Participants assessed average chronic prostatitis pain in the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no chronic prostatitis pain) to 10 (chronic prostatitis pain as bad as you can imagine). The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. Higher score indicated severe pain.
Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days. The change from baseline was calculated using difference between Week 6 mean score and Baseline mean score.
AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 12 weeks after last dose that were absent before treatment in this study or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events.
| Arm | Type | Description |
|---|---|---|
| Low dose | EXPERIMENTAL | Investigational product |
| High dose | EXPERIMENTAL | Investigational product |
| Placebo | PLACEBO_COMPARATOR | Investigational product |
| Tanezumab 2.5 mg | EXPERIMENTAL | tanezumab 2.5 mg administered subcutaneously at day 0 and week 8 |
| Tanezumab 2.5mg/5mg | EXPERIMENTAL | tanezumab 2.5 mg administered subcutaneously at day 0 and tanezumab 5 mg administered subcutaneously at week 8 |
| Arm 1 | EXPERIMENTAL | Tanezumab 20 mg subcutaneously |
| Arm 2 | PLACEBO_COMPARATOR | Placebo matched to active treatment subcutaneously |
| Placebo to Week 16; tanezumab 5 mg SC | PLACEBO_COMPARATOR | - |
| Placebo to Week 16, tanezumab 10 mg SC | PLACEBO_COMPARATOR | - |
| Tanezumab 5 mg SC | EXPERIMENTAL | - |
| Tanezumab 10 mg SC | EXPERIMENTAL | - |
| Tramadol PR oral | ACTIVE_COMPARATOR | - |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | ACTIVE_COMPARATOR | - |
| 4 | PLACEBO_COMPARATOR | - |
| Tanezumab 10 mg | EXPERIMENTAL | Tanezumab 10 mg IV every 8 weeks |
| Tanezumab 5 mg | EXPERIMENTAL | Tanezumab 5mg IV every 8 weeks |
| Tanezumab 20 mg IV | EXPERIMENTAL | - |
| Tanezumab 10 mg IV | EXPERIMENTAL | - |
| Tanezumab 5 mg IV | EXPERIMENTAL | - |
| Naproxen | ACTIVE_COMPARATOR | - |
| Tanezumab 10 mg IV + opioids | EXPERIMENTAL | - |
| Placebo + opioids | PLACEBO_COMPARATOR | Single IV infusion of placebo for tanezumab on Day 1. Maintained on baseline opioid regimen. |
| Tanezumab | EXPERIMENTAL | - |
| 5 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Tanezumab | DRUG | 2.5 mg |
| Placebo | DRUG | Placebo |
| Tanezumab 2.5 mg | BIOLOGICAL | Patient receives one dose of tanezumab 2.5 mg subcutaneously on Day 1 and one dose of tanezumab 2.5 mg subcutaneously at Week 8. |
| Tanezumab 2.5mg/5mg | BIOLOGICAL | Patient receives one dose of tanezumab 2.5 mg subcutaneously on Day 1 and one dose of tanezumab 5 mg subcutaneously at Week 8. |
| Placebo to Week 16; tanezumab 5mg SC | BIOLOGICAL | Placebo SC injection every 8 weeks for 2 injections followed by tanezumab 5 mg injection every 8 weeks for 5 injections |
| Placebo to Week 16, tanezumab 10 mg SC | BIOLOGICAL | Placebo SC injection every 8 weeks for 2 injections, followed by tanezumab 10 mg SC injection for 5 injections |
| Tanezumab 5 mg SC | BIOLOGICAL | Tanezumab 5 mg SC |
| Tanezumab 10 mg SC | BIOLOGICAL | Tanezumab 10 mg SC |
| Tramadol PR oral | BIOLOGICAL | Tramadol PR oral |
| tanezumab 10 mg | BIOLOGICAL | tanezumab 10 mg one dose at weeks 0 and 8 |
| tanezumab 5 mg | BIOLOGICAL | tanezumab 5 mg one dose at weeks 0 and 8 |
| naproxen | DRUG | naproxen 1000 mg daily for 16 weeks |
| Tanezumab 20 mg IV | BIOLOGICAL | 2 IV administrations of tanezumab 20 mg at an 8 week interval |
| Placebo for naproxen | DRUG | Oral placebo for naproxen twice a day for 16 weeks |
| Tanezumab 10 mg IV | BIOLOGICAL | 2 IV administrations of tanezumab 10 mg at an 8 week interval |
| Tanezumab 5 mg IV | BIOLOGICAL | 2 IV administrations of tanezumab 5 mg at an 8 week interval |
| Placebo for tanezumab | BIOLOGICAL | 2 IV administrations of placebo for tanezumab at an 8 week interval |
| IV Placebo for tanezumab | DRUG | Single IV infusion of placebo for tanezumab on Day 1. Maintained on baseline opioid regimen. |
| RN624 | DRUG | 50 mcg/kg |
| RN624 (PF-04383119) | DRUG | 50 mcg/kg |
Inclusion Criteria: * A diagnosis of osteoarthritis of the index hip or knee based on American College of Rheumatology criteria with Kellgren Lawrence x-ray Grade of at least 2 as diagnosed by the Central Reader * A history of insufficient pain relief from acetaminophen along with a history of insu...
RN624 is an investigational small molecule drug developed by Pfizer, Inc. for pain. It has been studied in Phase 2 clinical trials for postherpetic neuralgia and osteoarthritis, including knee pain. It is not described as approved and remains an investigational agent in clinical development.
RN624 has been studied for two pain indications: postherpetic neuralgia, which is nerve pain following shingles, and osteoarthritis, including moderate to severe knee pain. Both were evaluated in Phase 2 trials. No approved use has been established for RN624.
Pfizer, Inc. develops RN624. Pfizer trades on the New York Stock Exchange under the ticker PFE. The compound is also referenced as RN624 (PF-04383119).
RN624 is in Phase 2 development. Two completed Phase 2 trials are registered, and no active trials are listed. The studies together enrolled 737 participants. RN624 is investigational and has not been described as FDA approved for any indication.
Two completed Phase 2 trials studied RN624. NCT00568321 evaluated it for postherpetic neuralgia in 99 participants. NCT00394563 studied moderate to severe osteoarthritis knee pain in 450 participants, and NCT00399490 was an open-label extension study in osteoarthritis and knee pain with 287 participants. All were conducted in the United States.
Yes. RN624 is also known as RN624 (PF-04383119). Both names refer to the same investigational small molecule developed by Pfizer, Inc. for pain indications including postherpetic neuralgia and osteoarthritis.