Phase 2
Completed N=158
Phase 2, Multicenter, Open-Label Extension Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Study
Source: ClinicalTrials.gov NCT02433340 ↗Enrolled (actual)
158
Serious AEs
3.8%
Results posted
Jun 2017
Primary outcomePrimary: American College of Rheumatology (ACR) 20 Response Rate at Week 2 — 45.0; 43.2; 46.2; 47.4 percentage of participants
Summary
This is a Phase 2, multicenter, 24-week OLE study to assess the safety and tolerability of ABT-122 in participants with rheumatoid arthritis (RA) who had had an inadequate response to methotrexate (MTX) therapy and who completed the preceding Study M12-963 randomized controlled trial, in which participants had been randomized to receive 1 of 3 doses of ABT-122 (60 mg every other week [EOW], 120 mg EOW, or 120 mg every week [EW]) or adalimumab 40 mg EOW given on background methotrexate.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY American College of Rheumatology (ACR) 20 Response Rate at Week 2 |
45.0; 43.2; 46.2; 47.4; 45.5 | — |
| PRIMARY ACR20 Response Rate at Week 4 |
50.0; 64.9; 46.2; 74.4; 58.6 | — |
| PRIMARY ACR20 Response Rate at Week 6 |
66.7; 70.3; 66.7; 79.5; 70.7 | — |
| PRIMARY ACR20 Response Rate at Week 8 |
76.2; 75.7; 69.2; 80.0; 75.3 | — |
| PRIMARY ACR20 Response Rate at Week 12 |
78.6; 70.3; 84.6; 82.5; 79.1 | — |
| PRIMARY ACR20 Response Rate at Week 16 |
85.4; 77.8; 86.5; 77.5; 81.8 | — |
| PRIMARY ACR20 Response Rate at Week 20 |
71.4; 77.8; 82.1; 79.5; 77.6 | — |
| PRIMARY ACR20 Response Rate at Week 24 |
78.6; 77.8; 76.9; 84.6; 79.5 | — |
| PRIMARY ACR20 Response Rate at Week 28 |
73.8; 75.0; 74.4; 82.1; 76.3 | — |
| PRIMARY ACR20 Response Rate at Week 32 |
76.2; 72.2; 79.5; 80.0; 77.1 | — |
| PRIMARY ACR20 Response Rate at Week 36 |
71.4; 72.2; 84.6; 85.0; 78.3 | — |
| PRIMARY ACR50 Response Rate at Week 2 |
10.0; 8.1; 20.5; 23.1; 15.5 | — |
| PRIMARY ACR50 Response Rate at Week 4 |
14.3; 29.7; 23.1; 35.9; 25.5 | — |
| PRIMARY ACR50 Response Rate at Week 6 |
33.3; 35.1; 38.5; 42.5; 37.3 | — |
| PRIMARY ACR50 Response Rate at Week 8 |
45.2; 29.7; 41.0; 42.5; 39.9 | — |
| PRIMARY ACR50 Response Rate at Week 12 |
52.4; 37.8; 51.3; 46.2; 47.1 | — |
| PRIMARY ACR50 Response Rate at Week 16 |
36.6; 51.4; 56.8; 56.4; 50.0 | — |
| PRIMARY ACR50 Response Rate at Week 20 |
42.9; 52.8; 51.3; 52.5; 49.7 | — |
| PRIMARY ACR50 Response Rate at Week 24 |
40.5; 47.2; 53.8; 71.8; 53.2 | — |
| PRIMARY ACR50 Response Rate at Week 28 |
50.0; 47.2; 51.3; 69.2; 54.5 | — |
| PRIMARY ACR50 Response Rate at Week 32 |
45.2; 58.3; 51.3; 62.5; 54.1 | — |
| PRIMARY ACR50 Response Rate at Week 36 |
45.2; 50.0; 53.8; 62.5; 52.9 | — |
| PRIMARY ACR70 Response Rate at Week 2 |
0.0; 2.7; 5.1; 5.1; 3.2 | — |
| PRIMARY ACR70 Response Rate at Week 4 |
4.8; 10.8; 10.3; 17.5; 10.8 | — |
| PRIMARY ACR70 Response Rate at Week 6 |
16.7; 13.5; 17.9; 20.0; 17.1 | — |
| PRIMARY ACR70 Response Rate at Week 8 |
19.0; 8.1; 25.6; 27.5; 20.3 | — |
| PRIMARY ACR70 Response Rate at Week 12 |
23.8; 24.3; 20.5; 35.0; 25.9 | — |
| PRIMARY ACR70 Response Rate at Week 16 |
15.0; 30.6; 33.3; 25.6; 25.8 | — |
| PRIMARY ACR70 Response Rate at Week 20 |
19.0; 31.4; 33.3; 32.5; 28.8 | — |
| PRIMARY ACR70 Response Rate at Week 24 |
19.0; 25.0; 28.2; 40.0; 28.0 | — |
| PRIMARY ACR70 Response Rate at Week 28 |
16.7; 27.8; 30.8; 41.0; 28.8 | — |
| PRIMARY ACR70 Response Rate at Week 32 |
16.7; 27.8; 23.1; 42.5; 27.4 | — |
| PRIMARY ACR70 Response Rate at Week 36 |
23.8; 30.6; 35.9; 45.0; 33.8 | — |
| PRIMARY Summary of Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation, and Deaths |
17; 15; 19; 14; 65; 5 | — |
| SECONDARY Change From Baseline In Tender Joint Count (TJC68) at Week 2 |
-9.4; -11.6; -11.0; -12.9; -11.2 | — |
| SECONDARY Change From Baseline in TJC68 at Week 4 |
-13.1; -16.6; -13.6; -16.1; -14.8 | — |
| SECONDARY Change From Baseline in TJC68 at Week 6 |
-15.8; -16.9; -15.3; -16.6; -16.1 | — |
| SECONDARY Change From Baseline in TJC68 at Week 8 |
-17.3; -17.4; -17.1; -17.1; -17.2 | — |
| SECONDARY Change From Baseline in TJC68 at Week 12 |
-18.4; -16.9; -18.6; -18.0; -18.0 | — |
| SECONDARY Change From Baseline in TJC68 at Week 16 |
-18.3; -19.2; -17.6; -18.1; -18.3 | — |
| SECONDARY Change From Baseline in TJC68 at Week 20 |
-17.6; -19.7; -17.8; -19.0; -18.5 | — |
| SECONDARY Change From Baseline in TJC68 at Week 24 |
-19.3; -18.3; -17.4; -19.8; -18.7 | — |
| SECONDARY Change From Baseline in TJC68 at Week 28 |
-18.2; -18.9; -17.9; -21.0; -19.0 | — |
| SECONDARY Change From Baseline in TJC68 at Week 32 |
-18.2; -19.7; -17.9; -20.3; -19.0 | — |
| SECONDARY Change From Baseline in TJC68 at Week 36 |
-18.2; -18.5; -17.7; -20.3; -18.7 | — |
| SECONDARY Change From Baseline in Swollen Joint Count (SJC66) at Week 2 |
-8.0; -8.8; -8.6; -10.8; -9.0 | — |
| SECONDARY Change From Baseline in SJC66 at Week 4 |
-8.8; -10.6; -10.3; -13.3; -10.7 | — |
| SECONDARY Change From Baseline in SJC66 at Week 6 |
-11.8; -11.9; -12.3; -13.3; -12.3 | — |
| SECONDARY Change From Baseline in SJC66 at Week 8 |
-12.2; -12.4; -13.8; -14.3; -13.2 | — |
| SECONDARY Change From Baseline in SJC66 at Week 12 |
-12.6; -11.8; -13.4; -14.8; -13.2 | — |
| SECONDARY Change From Baseline in SJC66 at Week 16 |
-13.0; -13.5; -13.8; -14.5; -13.7 | — |
| SECONDARY Change From Baseline in SJC66 at Week 20 |
-12.2; -14.6; -13.8; -15.4; -14.0 | — |
| SECONDARY Change From Baseline in SJC66 at Week 24 |
-14.0; -13.8; -14.6; -15.6; -14.5 | — |
| SECONDARY Change From Baseline in SJC66 at Week 28 |
-13.3; -14.0; -14.9; -15.8; -14.5 | — |
| SECONDARY Change From Baseline in SJC66 at Week 32 |
-13.1; -13.9; -14.3; -14.9; -14.1 | — |
| SECONDARY Change From Baseline in SJC66 at Week 36 |
-12.4; -14.0; -15.0; -14.8; -14.0 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Pain at Week 2 |
-17.9; -20.1; -22.4; -22.3; -20.7 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Pain at Week 4 |
-24.5; -28.7; -24.8; -29.3; -26.8 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Pain at Week 6 |
-31.8; -29.1; -29.8; -29.9; -30.2 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Pain at Week 8 |
-30.5; -29.8; -30.2; -36.0; -31.7 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Pain at Week 12 |
-36.2; -29.3; -37.9; -36.5; -35.1 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Pain at Week 16 |
-31.9; -33.0; -35.0; -38.5; -34.6 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Pain at Week 20 |
-30.2; -40.3; -37.8; -36.8; -36.1 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Pain at Week 24 |
-31.7; -35.9; -32.0; -39.4; -34.7 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Pain at Week 28 |
-28.5; -36.2; -35.3; -40.1; -34.9 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Pain at Week 32 |
-27.3; -37.4; -34.3; -42.8; -35.3 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Pain at Week 36 |
-31.3; -36.1; -39.3; -41.8; -37.0 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Activity at Week 2 |
-18.1; -14.2; -21.3; -17.2; -17.7 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Activity at Week 4 |
-20.6; -25.6; -20.7; -26.6; -23.3 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Activity at Week 6 |
-26.5; -23.2; -26.9; -27.9; -26.2 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Activity at Week 8 |
-27.1; -26.8; -31.8; -34.1; -30.0 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Activity at Week 12 |
-29.2; -29.0; -34.1; -35.6; -32.0 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Activity at Week 16 |
-26.8; -29.3; -34.8; -35.8; -31.6 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Activity at Week 20 |
-28.5; -35.6; -35.4; -35.4; -33.6 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Activity at Week 24 |
-31.5; -33.1; -32.7; -38.9; -34.0 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Activity at Week 28 |
-25.0; -33.1; -32.6; -39.7; -32.5 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Activity at Week 32 |
-27.4; -34.2; -32.8; -43.8; -34.5 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Activity at Week 36 |
-29.5; -32.5; -37.5; -38.3; -34.4 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity at Week 2 |
-24.5; -25.8; -29.5; -26.5; -26.6 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity at Week 4 |
-28.6; -35.5; -34.5; -37.3; -33.8 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity at Week 6 |
-38.5; -39.0; -40.3; -40.1; -39.5 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity at Week 8 |
-41.0; -39.6; -45.6; -43.4; -42.4 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12 |
-44.4; -42.9; -49.7; -47.6; -46.2 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity at Week 16 |
-46.0; -45.3; -47.3; -47.3; -46.4 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity at Week 20 |
-44.3; -46.1; -45.6; -49.3; -46.3 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity at Week 24 |
-45.8; -46.7; -47.4; -49.9; -47.4 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity at Week 28 |
-44.5; -48.7; -48.2; -51.7; -48.2 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity at Week 32 |
-45.2; -50.0; -49.9; -51.7; -49.1 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity at Week 36 |
-42.4; -48.0; -50.5; -51.8; -48.1 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 2 |
-0.25; -0.31; -0.29; -0.40; -0.31 | — |
| SECONDARY Change From Baseline in HAQ-DI at Week 4 |
-0.37; -0.40; -0.47; -0.62; -0.47 | — |
| SECONDARY Change From Baseline in HAQ-DI at Week 6 |
-0.53; -0.46; -0.63; -0.64; -0.57 | — |
| SECONDARY Change From Baseline in HAQ-DI at Week 8 |
-0.56; -0.52; -0.65; -0.71; -0.61 | — |
| SECONDARY Change From Baseline in HAQ-DI at Week 12 |
-0.69; -0.55; -0.66; -0.88; -0.70 | — |
| SECONDARY Change From Baseline in HAQ-DI at Week 16 |
-0.59; -0.67; -0.67; -0.90; -0.71 | — |
| SECONDARY Change From Baseline in HAQ-DI at Week 20 |
-0.54; -0.73; -0.70; -0.88; -0.71 | — |
| SECONDARY Change From Baseline in HAQ-DI at Week 24 |
-0.63; -0.74; -0.60; -0.91; -0.72 | — |
| SECONDARY Change From Baseline in HAQ-DI at Week 28 |
-0.60; -0.77; -0.69; -0.99; -0.76 | — |
| SECONDARY Change From Baseline in HAQ-DI at Week 32 |
-0.54; -0.76; -0.66; -0.91; -0.71 | — |
| SECONDARY Change From Baseline in HAQ-DI at Week 36 |
-0.62; -0.73; -0.71; -0.81; -0.72 | — |
| SECONDARY Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 2 |
-12.6; -9.9; -12.6; -14.9; -12.5 | — |
| SECONDARY Change From Baseline in hsCRP at Week 4 |
-13.3; -8.0; -11.7; -14.6; -12.0 | — |
| SECONDARY Change From Baseline in hsCRP at Week 6 |
-13.3; -8.0; -10.7; -14.9; -11.8 | — |
| SECONDARY Change From Baseline in hsCRP at Week 8 |
-12.2; -8.0; -10.7; -12.9; -11.0 | — |
| SECONDARY Change From Baseline in hsCRP at Week 12 |
-12.3; -6.5; -10.8; -14.6; -11.2 | — |
| SECONDARY Change From Baseline in hsCRP at Week 16 |
-13.5; -5.5; -10.8; -12.5; -10.7 | — |
| SECONDARY Change From Baseline in hsCRP at Week 20 |
-11.6; -6.4; -10.3; -11.6; -10.1 | — |
| SECONDARY Change From Baseline in hsCRP at Week 24 |
-11.3; -6.7; -9.1; -10.8; -9.6 | — |
| SECONDARY Change From Baseline in hsCRP at Week 28 |
-3.5; -6.3; -11.3; -6.8; -6.9 | — |
| SECONDARY Change From Baseline in hsCRP at Week 32 |
-9.8; -7.6; -8.0; -10.4; -9.0 | — |
| SECONDARY Change From Baseline in hsCRP at Week 36 |
-8.7; -6.0; -8.7; -9.0; -8.1 | — |
| SECONDARY Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 2 |
-1.5; -1.5; -1.8; -1.7; -1.6 | — |
| SECONDARY Change From Baseline in DAS28 (hsCRP) at Week 4 |
-1.9; -2.1; -2.1; -2.3; -2.1 | — |
| SECONDARY Change From Baseline in DAS28 (hsCRP) at Week 6 |
-2.4; -2.2; -2.5; -2.4; -2.4 | — |
| SECONDARY Change From Baseline in DAS28 (hsCRP) at Week 8 |
-2.4; -2.3; -2.7; -2.6; -2.5 | — |
| SECONDARY Change From Baseline in DAS28 (hsCRP) at Week 12 |
-2.6; -2.3; -2.8; -2.7; -2.6 | — |
| SECONDARY Change From Baseline in DAS28 (hsCRP) at Week 16 |
-2.7; -2.6; -2.8; -2.6; -2.7 | — |
| SECONDARY Change From Baseline in DAS28 (hsCRP) at Week 20 |
-2.7; -2.8; -2.7; -2.8; -2.7 | — |
| SECONDARY Change From Baseline in DAS28 (hsCRP) at Week 24 |
-2.8; -2.6; -2.7; -2.9; -2.8 | — |
| SECONDARY Change From Baseline in DAS28 (hsCRP) at Week 28 |
-2.5; -2.7; -2.9; -2.9; -2.7 | — |
| SECONDARY Change From Baseline in DAS28 (hsCRP) at Week 32 |
-2.6; -2.8; -2.7; -2.9; -2.8 | — |
| SECONDARY Change From Baseline in DAS28 (hsCRP) at Week 36 |
-2.6; -2.6; -2.8; -2.8; -2.7 | — |
| SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 2 |
-15.9; -17.4; -17.5; -18.2; -17.3 | — |
| SECONDARY Change From Baseline in CDAI at Week 4 |
-20.3; -24.6; -22.1; -24.3; -22.7 | — |
| SECONDARY Change From Baseline in CDAI at Week 6 |
-25.7; -25.6; -25.8; -25.6; -25.7 | — |
| SECONDARY Change From Baseline in CDAI at Week 8 |
-26.7; -27.0; -28.2; -27.4; -27.3 | — |
| SECONDARY Change From Baseline in CDAI at Week 12 |
-28.4; -27.2; -29.7; -28.8; -28.5 | — |
| SECONDARY Change From Baseline in CDAI at Week 16 |
-28.1; -29.9; -28.5; -29.6; -29.0 | — |
| SECONDARY Change From Baseline in CDAI at Week 20 |
-28.1; -31.8; -28.2; -31.1; -29.7 | — |
| SECONDARY Change From Baseline in CDAI at Week 24 |
-30.7; -30.1; -28.8; -31.0; -30.1 | — |
| SECONDARY Change From Baseline in CDAI at Week 28 |
-28.1; -31.4; -29.8; -32.7; -30.4 | — |
| SECONDARY Change From Baseline in CDAI at Week 32 |
-28.5; -32.4; -29.1; -31.6; -30.3 | — |
| SECONDARY Change From Baseline in CDAI at Week 36 |
-27.6; -30.9; -30.0; -30.9; -29.8 | — |
| SECONDARY Low Disease Activity (LDA) or Clinical Remission (CR) Response Rate Per DAS28 (hsCRP) at Week 2 |
12.5; 8.1; 28.2; 25.6; 18.7 | — |
| SECONDARY LDA or CR Response Rate Per DAS28 (hsCRP) at Week 4 |
31.0; 32.4; 30.8; 45.0; 34.8 | — |
| SECONDARY LDA or CR Response Rate Per DAS28 (hsCRP) at Week 6 |
45.2; 24.3; 43.6; 50.0; 41.1 | — |
| SECONDARY LDA or CR Response Rate Per DAS28 (hsCRP) at Week 8 |
45.2; 27.0; 53.8; 55.0; 45.6 | — |
| SECONDARY LDA or CR Response Rate Per DAS28 (hsCRP) at Week 12 |
50.0; 35.1; 56.4; 52.5; 48.7 | — |
| SECONDARY LDA or CR Response Rate Per DAS28 (hsCRP) at Week 16 |
51.2; 52.8; 62.2; 48.7; 53.6 | — |
| SECONDARY LDA or CR Response Rate Per DAS28 (hsCRP) at Week 20 |
54.8; 55.6; 56.4; 60.0; 56.7 | — |
| SECONDARY LDA or CR Response Rate Per DAS28 (hsCRP) at Week 24 |
61.9; 44.4; 56.4; 60.0; 56.1 | — |
| SECONDARY LDA or CR Response Rate Per DAS28 (hsCRP) at Week 28 |
47.6; 41.7; 56.4; 55.0; 50.3 | — |
| SECONDARY LDA or CR Response Rate Per DAS28 (hsCRP) at Week 32 |
52.4; 52.8; 61.5; 60.0; 56.7 | — |
| SECONDARY LDA or CR Response Rate Per DAS28 (hsCRP) at Week 36 |
54.8; 41.7; 59.0; 47.5; 51.0 | — |
| SECONDARY CR Response Rate Per DAS28 (hsCRP) at Week 2 |
5.0; 5.4; 12.8; 10.3; 8.4 | — |
| SECONDARY CR Response Rate Per DAS28 (hsCRP) at Week 4 |
14.3; 8.1; 23.1; 25.0; 17.7 | — |
| SECONDARY CR Response Rate Per DAS28 (hsCRP) at Week 6 |
31.0; 18.9; 33.3; 27.5; 27.8 | — |
| SECONDARY CR Response Rate Per DAS28 (hsCRP) at Week 8 |
28.6; 21.6; 38.5; 37.5; 31.6 | — |
| SECONDARY CR Response Rate Per DAS28 (hsCRP) at Week 12 |
31.0; 21.6; 38.5; 40.0; 32.9 | — |
| SECONDARY CR Response Rate Per DAS28 (hsCRP) at Week 16 |
39.0; 30.6; 37.8; 30.8; 34.6 | — |
| SECONDARY CR Response Rate Per DAS28 (hsCRP) at Week 20 |
40.5; 36.1; 25.6; 37.5; 35.0 | — |
| SECONDARY CR Response Rate Per DAS28 (hsCRP) at Week 24 |
33.3; 30.6; 38.5; 45.0; 36.9 | — |
| SECONDARY CR Response Rate Per DAS28 (hsCRP) at Week 28 |
33.3; 27.8; 38.5; 42.5; 35.7 | — |
| SECONDARY CR Response Rate Per DAS28 (hsCRP) at Week 32 |
38.1; 38.9; 35.9; 45.0; 39.5 | — |
| SECONDARY CR Response Rate Per DAS28 (hsCRP) at Week 36 |
38.1; 19.4; 43.6; 37.5; 35.0 | — |
| SECONDARY LDA or CR Response Rate Per CDAI at Week 2 |
7.7; 5.4; 12.8; 15.4; 10.4 | — |
| SECONDARY LDA or CR Response Rate Per CDAI at Week 4 |
23.8; 21.6; 23.1; 35.0; 25.9 | — |
| SECONDARY LDA or CR Response Rate Per CDAI at Week 6 |
40.5; 21.6; 43.6; 45.0; 38.0 | — |
| SECONDARY LDA or CR Response Rate Per CDAI at Week 8 |
35.7; 27.0; 46.2; 47.5; 39.2 | — |
| SECONDARY LDA or CR Response Rate Per CDAI at Week 12 |
40.5; 37.8; 46.2; 50.0; 43.7 | — |
| SECONDARY LDA or CR Response Rate Per CDAI at Week 16 |
47.5; 45.7; 55.6; 50.0; 49.7 | — |
| SECONDARY LDA or CR Response Rate Per CDAI at Week 20 |
47.6; 45.7; 36.8; 56.4; 46.8 | — |
| SECONDARY LDA or CR Response Rate Per CDAI at Week 24 |
54.8; 44.4; 43.6; 60.0; 51.0 | — |
| SECONDARY LDA or CR Response Rate Per CDAI at Week 28 |
47.6; 44.4; 48.7; 60.0; 50.3 | — |
| SECONDARY LDA or CR Response Rate Per CDAI at Week 32 |
42.9; 55.6; 51.3; 60.0; 52.2 | — |
| SECONDARY LDA or CR Response Rate Per CDAI at Week 36 |
52.4; 44.4; 59.0; 60.0; 54.1 | — |
| SECONDARY CR Response Rate Per CDAI Criteria at Week 2 |
0.0; 0.0; 2.6; 0.0; 0.6 | — |
| SECONDARY CR Response Rate Per CDAI Criteria at Week 4 |
0.0; 2.7; 5.1; 5.0; 3.2 | — |
| SECONDARY CR Response Rate Per CDAI Criteria at Week 6 |
2.4; 0.0; 10.3; 5.0; 4.4 | — |
| SECONDARY CR Response Rate Per CDAI Criteria at Week 8 |
4.8; 0.0; 17.9; 17.5; 10.1 | — |
| SECONDARY CR Response Rate Per CDAI Criteria at Week 12 |
7.1; 8.1; 12.8; 12.5; 10.1 | — |
| SECONDARY CR Response Rate Per CDAI Criteria at Week 16 |
7.5; 5.7; 11.1; 15.8; 10.1 | — |
| SECONDARY CR Response Rate Per CDAI Criteria at Week 20 |
9.5; 11.4; 15.8; 17.9; 13.6 | — |
| SECONDARY CR Response Rate Per CDAI Criteria at Week 24 |
7.1; 5.6; 23.1; 20.0; 14.0 | — |
| SECONDARY CR Response Rate Per CDAI Criteria at Week 28 |
9.5; 5.6; 20.5; 20.0; 14.0 | — |
| SECONDARY CR Response Rate Per CDAI Criteria at Week 32 |
7.1; 5.6; 12.8; 15.0; 10.2 | — |
| SECONDARY CR Response Rate Per CDAI Criteria at Week 36 |
9.5; 11.1; 17.9; 15.0; 13.4 | — |
Eligibility Criteria
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:
- Postmenopausal (defined as no menses for at least 1 year).
- Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
- Practicing appropriate birth control, from the time of enrollment in this study until at least 150 days after the last dose of study drug.
- Male who agrees to follow one of the protocol-specified pregnancy avoidance measures, including refraining from donating sperm, for up to 150 days post last dose of study drug.
- Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
- Subject is judged to be in good health as determined by the Investigator based on the results of medical history, physical examination and laboratory profile performed.
Exclusion Criteria: - Pregnant or breastfeeding female.
- Ongoing infections at Day 1 (Week 0) that have NOT been successfully treated within 14 days.
- Anticipated requirement or receipt of any live vaccine during study participation including up to 120 days after the last dose of study drug.
- Current enrollment in another investigational study; with the exception of Study M12-963, which is required.
- Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-122.
Data sourced from ClinicalTrials.gov (NCT02433340). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.