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

NCT02141997 | Completed Phase 2 Results DMC

• 2 other identifiers: M12-9632013-004019-37
• Study Type: interventional
• Target: 222
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

efficacy; Methotrexate; safety

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12

  Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP). Last observation carried forward (LOCF) was used for missing data (only post-baseline values were carried forward).

  Baseline (Day 1) and Week 12

Secondary Outcomes (7)

• Change in Disease Activity Score 28 With High Sensitivity C-Reactive Protein (DAS28 [hsCRP])

  Baseline, Weeks 2, 4, 6, 8, and 12

• Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 12

  Baseline (Day 1) and Week 12

• Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12

  Baseline (Day 1) and Week 12

• Percentage of Participants Achieving Low Disease Activity (LDA) or Clinical Remission (CR) Based on DAS28 (hsCRP) at Week 12

  Week 12

• Percentage of Participants Achieving CR Based on DAS28 (hsCRP) at Week 12

  Week 12

Study Arms (4)

Adalimumab 40 mg EOW

ACTIVE COMPARATOR

Adalimumab 40 mg every other week (EOW) for 11 weeks.

Biological: adalimumab

ABT-122 60 mg EOW

EXPERIMENTAL

ABT-122 60 mg every other week (EOW) for 11 weeks.

Biological: ABT-122

ABT-122 120 mg EOW

EXPERIMENTAL

ABT-122 120 mg every other week (EOW) for 11 weeks.

Biological: ABT-122

ABT-122 120 mg EW

EXPERIMENTAL

ABT-122 120 mg every week (EW) for 11 weeks.

Biological: ABT-122

Interventions

adalimumab BIOLOGICAL

adalimumab administered as subcutaneous injection every other week (EOW)

Also known as: Humira

Adalimumab 40 mg EOW

ABT-122 BIOLOGICAL

ABT-122 administered as subcutaneous injection every other week (EOW)

ABT-122 120 mg EOW; ABT-122 120 mg EW; ABT-122 60 mg EOW

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \< 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.

You may not qualify if:

• Subject has previous exposure to Humira, other Tumor necrosis factor (TNF) inhibitors or other biological DMARDs.
• 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.
• Stable prescribed dose of oral prednisone or prednisone equivalent \> 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 \< 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.

Sponsors & Collaborators

• AbbVie: lead

Related Publications (1)

• 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.

  PMID: 29855172 DERIVED

Related Links

• Humira Prescribing info

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab; ABT-122

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Information
• Organization: AbbVie

1-800-633-9110

Study Officials

• Heikki Mansikka, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: May 20, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 11, 2016
• Results First Posted: November 11, 2016

Record last verified: 2016-09