Phase 2
Completed N=240
A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis (PsA) Who Have an Inadequate Response to Methotrexate (MTX)
Source: ClinicalTrials.gov NCT02349451 ↗Enrolled (actual)
240
Serious AEs
0.8%
Results posted
Aug 2017
Primary outcomePrimary: American College of Rheumatology (ACR) 20 Response Rate at Week 12: ABT-122 Versus Placebo — 25.0; 64.8; 75.3 percentage of participants — p=<0.001
Summary
This study is a Phase 2 randomized, double-blind, double-dummy, active- and placebo-controlled, parallel-group study designed to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of multiple doses of ABT-122 in participants with active PsA who are inadequately responding to MTX treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY American College of Rheumatology (ACR) 20 Response Rate at Week 12: ABT-122 Versus Placebo |
25.0; 64.8; 75.3 | <0.001 sig |
| SECONDARY ACR20 Response Rate at Week 12: ABT-122 Versus Adalimumab |
68.1; 64.8; 75.3 | 0.723 |
| SECONDARY ACR50 Response Rate at Week 12 |
12.5; 37.5; 36.6; 53.4 | 0.021 sig |
| SECONDARY ACR70 Response Rate at Week 12 |
4.2; 15.3; 22.5; 31.5 | 0.034 sig |
| SECONDARY ACRn at Week 12 |
-20.3; 38.2; 34.7; 48.6 | <0.001 sig |
| SECONDARY Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 12 |
-0.89; -1.83; -1.96; -2.28 | <0.001 sig |
| SECONDARY Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Week 12 |
-1.46; -2.53; -2.62; -2.86 | <0.001 sig |
| SECONDARY Change From Baseline in Psoriasis Target Lesion Score at Week 12 |
-1.81; -4.16; -4.98; -4.53 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- PsA diagnosis of at least 3 months duration prior to the date of first screening with ClASsification of Psoriatic ARthritis (CASPAR) confirmed diagnosis at Screening.
- Have active psoriasis defined by at least 1 psoriasis lesion >= 2 cm diameter in areas other than the axilla or groin.
- Have active arthritis defined by minimum disease activity criteria:
- >= 3 swollen joints (based on 66 joint counts) at Screening
- >= 3 tender joints (based on 68 joint counts) at Screening
- On a stable dose of methotrexate (MTX) defined as:
- Oral or parenteral treatment >= 3 months
- On a stable dose with an unchanged mode of application for at least 4 weeks prior to baseline
- Stable MTX dose of >= 10 mg/week and 10 mg/day within the 30 days of the Baseline visit.
- Intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks of the Baseline visit. Inhaled corticosteroids for stable medical conditions are allowed.
- Laboratory values of the following at the Screening Visit:
- Confirmed hemoglobin 1.5 x the upper limit of normal (ULN) or bilirubin >= 3 mg/dL
- Serum creatinine > 1.5 x the ULN
- Platelets < 100,000 cells/[mm^3] (10^9/L),
- Clinically significant abnormal screening laboratory results as evaluated by the Investigator
Data sourced from ClinicalTrials.gov (NCT02349451). 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.