Phase 2
Completed N=222
A Study to Investigate the Safety and Efficacy of ABT-122 Given With Methotrexate in Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
Source: ClinicalTrials.gov NCT02141997 ↗Enrolled (actual)
222
Serious AEs
1.8%
Results posted
Nov 2016
Primary outcomePrimary: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 — 73.2; 65.5; 76.8; 81.8 percentage of participants — p==0.863
Summary
This study is a Phase 2 randomized, double-blind, double-dummy, parallel-group study designed to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of multiple doses of ABT 122 in subjects with active rheumatoid arthritis (RA) who are inadequately responding to methotrexate (MTX) treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 |
73.2; 65.5; 76.8; 81.8 | =0.863 |
| SECONDARY Change in Disease Activity Score 28 With High Sensitivity C-Reactive Protein (DAS28 [hsCRP]) |
-1.43; -1.26; -1.80; -1.69; -1.86; -1.66 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 12 |
51.8; 34.5; 48.2; 48.1 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12 |
23.2; 23.6; 19.6; 36.4 | — |
| SECONDARY Percentage of Participants Achieving Low Disease Activity (LDA) or Clinical Remission (CR) Based on DAS28 (hsCRP) at Week 12 |
50.0; 34.5; 53.6; 54.5 | — |
| SECONDARY Percentage of Participants Achieving CR Based on DAS28 (hsCRP) at Week 12 |
32.1; 23.6; 39.3; 41.8 | — |
| SECONDARY Percentage of Participants Achieving LDA or CR Based on Clinical Disease Activity Index (CDAI) at Week 12 |
42.9; 36.4; 44.6; 54.5 | — |
| SECONDARY Percentage of Participants Achieving CR Based on Clinical Disease Activity Index (CDAI) at Week 12 |
8.9; 7.3; 10.7; 10.9 | — |
Eligibility Criteria
Inclusion Criteria
- Adult male or female, 18 years of age or older.
- Diagnosis of RA based on the 2010 American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) criteria (as defined in the definition of terms).
- Rheumatoid Arthritis (RA) diagnosis at least 3 months from the date of first Screening.
- Have active RA defined by minimum disease activity criteria:
- ≥ 6 Swollen joints (based on 66 joint counts) at screening and baseline visits.
- ≥ 6 Tender joints (based on 68 joint counts) at screening and baseline visits.
- hsCRP> ULN OR positive for both Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody levels at screening.
- Inadequate response to Methotrexate (MTX) treatment defined as oral or parenteral treatment ≥ 3 months with an unchanged mode of application and stable prescribed MTX dose for at least 4 weeks prior to baseline of ≥ 10mg/week and 10 mg/day within the 30 days of first dose of study drug.
- Intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks of first dose of study drug. Inhaled corticosteroids for stable medical conditions are allowed.
- Laboratory values of the following at the Screening Visit:
- Confirmed hemoglobin 1.5 × the upper limit of normal (ULN) or bilirubin ≥ 3 mg/dL,
- Serum creatinine > 1.5 × the ULN,
- Platelets < 100,000 cells/[mm3] (10^9/L),
- Clinically significant abnormal screening laboratory results as evaluated by the Investigator.
Data sourced from ClinicalTrials.gov (NCT02141997). 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.