Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Remtolumab
ABT-122 · 2 trials · 1 indication
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. An SAE is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
Collect all adverse events at each visit
Blood pressure, pulse and body temperature
Hematology, Chemistry, and Urinalysis
ECGs done in triplicate
Cmax, Tmax, AUC, elimination rate constant and half-life
| Arm | Type | Description |
|---|---|---|
| ABT-122 120 mg EOW | EXPERIMENTAL | All subjects receive open-label ABT-122 120 mg EOW subcutaneously, with the first dose administered at the last visit of Study M12-963 randomized controlled trial. |
| Group 1 | EXPERIMENTAL | Randomized 6 drug/2 placebo by group |
| Group 2 | EXPERIMENTAL | Randomized 6 drug/2 placebo by group |
| Group 3 | EXPERIMENTAL | Randomized 6 drug/2 placebo by group |
| Name | Type | Description |
|---|---|---|
| ABT-122 | DRUG | - |
| Placebo | BIOLOGICAL | Placebo Injection |
Inclusion Criteria: - Subjects who have completed the preceding Study M12-963 (ABT-122) randomized controlled study and have not developed any discontinuation criteria, as defined in Study M12-963. * If female, subject must meet one of the following criteria: 1. Postmenopausal (defined as no men...
Top 20 of 31 competitors
ABT-122 was developed for the treatment of rheumatoid arthritis, an inflammatory joint disease. It was studied in adults 18 years and older with the condition. Development reached Phase 2, and the clinical program has concluded, with both of its registered trials completed.
ABT-122 was developed by AbbVie Inc., the biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie sponsored the clinical studies of the drug in rheumatoid arthritis.
ABT-122 reached Phase 2 clinical development for rheumatoid arthritis. It is an investigational monoclonal antibody and is not an approved therapy. Both registered trials of the drug are completed, and no trials are currently active.
Two completed trials studied ABT-122 in rheumatoid arthritis. NCT02433340 was a Phase 2 open-label extension study in 158 subjects who finished the preceding M12-963 study. NCT01853033 was a Phase 1 study of multiple subcutaneous injections in 19 subjects in the United States.
The ABT-122 trials were randomized, double-blind, and controlled, with a combined enrollment of 177 participants. NCT01853033 evaluated safety, tolerability, and pharmacokinetics of multiple subcutaneous injections. NCT02433340 was an open-label extension for rheumatoid arthritis subjects who had completed the earlier M12-963 study.