A Phase 2 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
- Conditions
- Rheumatoid ArthritisMedDRA version: 17.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2013-004019-37-RO
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 222
1. Adult male or female, 18 years of age or older.
2. 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).
3. RA diagnosis at least 3 months from the date of first Screening.
4. Documented positive Rheumatoid Factor (RF) or Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody levels prior to or at Screening:
• If RF and Anti-CCP Antibody tests are negative, documented evidence of prior erosions on radiographs or CT/MRI of hands is an acceptable alternative for meeting this inclusion criterion.
5. Have active RA defined by minimum disease activity criteria:
• = 6 Swollen joints (based on 66 joint counts) at Screening,
• = 6 Tender joints (based on 68 joint counts) at Screening,
• hsCRP > Upper limit of normal at Screening.
6. Inadequate response to 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 = 10 mg/week and < the upper limit of the applicable approved local label. Subject can also be on stable doses of sulfasalazine and/or hydroxychloroquine, so long as they are also on methotrexate.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 104
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56
1. Subject has previous exposure to Humira, other TNF inhibitors or other biological DMARDs.
2. Current treatment with traditional oral DMARDs (except for concomitant treatment with sulfasalazine and/or hydroxychloroquine in addition to MTX). Oral DMARDs must be washed out 5 times the mean terminal elimination half-life of a drug apart from MTX prior to Day 1.
• Subject could have been exposed to prior JAK inhibitors so long as they have been off therapy for 5 half-lives.
3. Stable prescribed dose of oral prednisone or prednisone equivalent > 10 mg/day within the 30 days of first dose of study drug.
4. 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.
5. Laboratory values of the following at the Screening Visit:
• Confirmed hemoglobin < 9 g/dL for males and < 8.5 g/dL for females,
• Absolute neutrophil count (ANC) < 1500 /mm3,
• AST or ALT > 1.5 × the upper limit of normal (ULN) or bilirubin = 3 mg/dL,
• Serum creatinine > 1.5 × the ULN,
• Platelets < 100,000 cells/[mm3] (109/L),
• Clinically significant abnormal screening laboratory results as evaluated by the Investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method