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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT02141997
• Date of registration: 16/05/2014
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: 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
• Scientific title: 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
• Date of first enrolment: July 2014
• Target sample size: 222
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02141997
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Australia, Bulgaria, Canada, Czech Republic, Germany, Hungary, New Zealand, Poland, Romania, Turkey, United States

Contacts

• Name: Heikki Mansikka, MD
• Affiliation: AbbVie

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: adalimumab

Biological: ABT-122

Primary Outcome(s)

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 [Time Frame: Baseline (Day 1) and Week 12]

Secondary Outcome(s)

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 12 [Time Frame: Baseline (Day 1) and Week 12]

Percentage of Participants Achieving CR Based on Clinical Disease Activity Index (CDAI) at Week 12 [Time Frame: Week 12]

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12 [Time Frame: Baseline (Day 1) and Week 12]

Change in Disease Activity Score 28 With High Sensitivity C-Reactive Protein (DAS28 [hsCRP]) [Time Frame: Baseline, Weeks 2, 4, 6, 8, and 12]

Percentage of Participants Achieving CR Based on DAS28 (hsCRP) at Week 12 [Time Frame: Week 12]

Percentage of Participants Achieving LDA or CR Based on Clinical Disease Activity Index (CDAI) at Week 12 [Time Frame: Week 12]

Percentage of Participants Achieving Low Disease Activity (LDA) or Clinical Remission (CR) Based on DAS28 (hsCRP) at Week 12 [Time Frame: Week 12]

Secondary ID(s)

2013-004019-37

M12-963

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/11/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02141997