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ABT-981 · 3 trials · 4 indications
The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The pain subdomain score ranges from 0 to 50; lower scores indicate better status. A decrease in the pain subdomain score represents improvement in status. Last Observation Carried Forward (LOCF): Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.
The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) numerical rating scale (NRS). The pain sub-score has a range of 0 (no pain) to 50 (maximum pain). A negative change from baseline indicates improvement.
Change in synovitis of the index knee was evaluated using quantitative magnetic resonance imaging (MRI) measurements. MRI quantitative synovitis of the index knee was defined by mean synovial membrane thickness.
Semi-quantitative synovitis/effusion volume WORMS scores were scored as normal (0), \< 33% of maximum estimated distention (1), 33% - 66% of maximum estimated distention (2), or \> 66% of maximum estimated distention (3).
Collect all adverse events at each visit
Blood pressure, heart rate and body temperature
Hematology, Chemistry, and Urinalysis
ECGs done in triplicate
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| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo for ABT-981 every two weeks (Q2W) for 24 weeks. |
| ABT-981 | EXPERIMENTAL | ABT-981 200 mg every two weeks (Q2W) for 24 weeks. |
| ABT-981 low dose | EXPERIMENTAL | 25 mg ABT-981 subcutaneous (SC) every 2 weeks (E2W) |
| ABT-981 medium dose | EXPERIMENTAL | 100 mg ABT-981 SC E2W |
| ABT-981 high dose | EXPERIMENTAL | 200 mg ABT-981 SC E2W |
| Group 1 | EXPERIMENTAL | Randomized 7 drug/2 placebo by group |
| Group 2 | EXPERIMENTAL | Randomized 7 drug/2 placebo by group |
| Group 3 | EXPERIMENTAL | Randomized 7 drug/2 placebo by group |
| Group 4 | EXPERIMENTAL | Randomized 7 drug/2 placebo by group |
| Name | Type | Description |
|---|---|---|
| ABT-981 | BIOLOGICAL | ABT-981 administered by subcutaneous injection |
| Placebo for ABT-981 | BIOLOGICAL | Placebo for ABT-981 administered by subcutaneous injection |
| Placebo | OTHER | - |
Inclusion Criteria: 1. Male or female between the ages of 35 to 80. 2. Must fulfill 1990 American College of Rheumatology (ACR) hand osteoarthritis (OA) criteria 3. Must have radiographic evidence of erosive hand OA 4. Have one or more clinical signs and symptoms of active inflammation in at least ...
ABT-981 is an investigational monoclonal antibody being studied for the treatment of osteoarthritis, including knee osteoarthritis and erosive hand osteoarthritis. It is being developed by AbbVie Inc. (ABBV) and has completed clinical trials in these patient populations.
ABT-981 is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. The drug is being investigated for its effects on osteoarthritis, a degenerative joint disease.
ABT-981 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie has sponsored clinical trials evaluating the safety and efficacy of ABT-981 in patients with osteoarthritis.
ABT-981 has completed Phase 2 clinical trials for knee osteoarthritis and erosive hand osteoarthritis. It is an investigational drug and has not been approved by the FDA. The drug remains in clinical development, with no active trials currently listed.
ABT-981 has been studied in three completed clinical trials. NCT01668511 was a Phase 1 study in 36 patients with knee osteoarthritis. NCT02087904 was a Phase 2 study in 350 patients with knee osteoarthritis. NCT02384538 was a Phase 2a study in 132 patients with erosive hand osteoarthritis.
ABT-981 is the primary name used in clinical trial registrations for this investigational monoclonal antibody. No alternative names have been reported in the available clinical trial information.