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
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: adalimumab; ABT-122
Intervention description: adalimumab administered as subcutaneous injection every other week (EOW); ABT-122 administered as subcutaneous injection every other week (EOW)
Intervention MeSH terms: Adalimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 222.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: efficacy; Methotrexate; safety

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.
    

Eligibility criteria:

        Inclusion Criteria:

          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. Rheumatoid Arthritis (RA) diagnosis at least 3 months from the date of first
             Screening.

          4. 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.

          5. 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 < 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.

        Exclusion Criteria:

          1. Subject has previous exposure to Humira, other Tumor necrosis factor (TNF) inhibitors
             or other biological DMARDs.

          2. Current treatment with traditional oral Disease modifying antirheumatic drugs (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 Janus kinase (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 mm^3,

               -  Aspartate aminotransferase (AST) or alanine aminotransferase (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] (10^9/L),

               -  Clinically significant abnormal screening laboratory results as evaluated by the
                  Investigator.