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
NCT ID: NCT02141997
Last Updated: 2016-11-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
222 participants
INTERVENTIONAL
2014-07-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Adalimumab 40 mg EOW
Adalimumab 40 mg every other week (EOW) for 11 weeks.
adalimumab
adalimumab administered as subcutaneous injection every other week (EOW)
ABT-122 60 mg EOW
ABT-122 60 mg every other week (EOW) for 11 weeks.
ABT-122
ABT-122 administered as subcutaneous injection every other week (EOW)
ABT-122 120 mg EOW
ABT-122 120 mg every other week (EOW) for 11 weeks.
ABT-122
ABT-122 administered as subcutaneous injection every other week (EOW)
ABT-122 120 mg EW
ABT-122 120 mg every week (EW) for 11 weeks.
ABT-122
ABT-122 administered as subcutaneous injection every other week (EOW)
Interventions
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adalimumab
adalimumab administered as subcutaneous injection every other week (EOW)
ABT-122
ABT-122 administered as subcutaneous injection every other week (EOW)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
99 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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Heikki Mansikka, MD
Role: STUDY_DIRECTOR
AbbVie
Countries
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References
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Genovese MC, Weinblatt ME, Aelion JA, Mansikka HT, Peloso PM, Chen K, Li Y, Othman AA, Khatri A, Khan NS, Padley RJ. ABT-122, a Bispecific Dual Variable Domain Immunoglobulin Targeting Tumor Necrosis Factor and Interleukin-17A, in Patients With Rheumatoid Arthritis With an Inadequate Response to Methotrexate: A Randomized, Double-Blind Study. Arthritis Rheumatol. 2018 Nov;70(11):1710-1720. doi: 10.1002/art.40580. Epub 2018 Oct 10.
Related Links
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Humira Prescribing info
Other Identifiers
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2013-004019-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M12-963
Identifier Type: -
Identifier Source: org_study_id