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

Rheumatoid Arthritis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02141997
• Other study ID #: M12-963
• Secondary ID: 2013-004019-37
• Status: Completed
• Phase: Phase 2
• First received: May 16, 2014
• Last updated: December 1, 2015
• Start date: February 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug ControlTurkey: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsBulgaria: Bulgarian Drug AgencyNew Zealand: MedsafeHungary: National Institute of PharmacyGermany: Paul-Ehrlich-InstitutAustralia: Department of Health and Ageing Therapeutic Goods AdministrationCanada: Health CanadaRomania: National Agency for Medicines and Medical DevicesUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 RA who are inadequately responding to MTX treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• adalimumab
Double-blind Every Other Week (EOW)
• ABT-122
Double-Blind Every Week (EW)/ EOW

Locations

Country	Name	City	State
Bulgaria	Site Reference ID/Investigator# 128180	Plovdiv
Bulgaria	Site Reference ID/Investigator# 131189	Sofia
Bulgaria	Site Reference ID/Investigator# 131190	Sofia
Czech Republic	Site Reference ID/Investigator# 128157	Hlucin
Czech Republic	Site Reference ID/Investigator# 128155	Ostrava-Trebovice
Czech Republic	Site Reference ID/Investigator# 128158	Prague 5
Czech Republic	Site Reference ID/Investigator# 128156	Praha-zapad
Czech Republic	Site Reference ID/Investigator# 136884	Uherske Hradiste
Czech Republic	Site Reference ID/Investigator# 136886	Zlin
Germany	Site Reference ID/Investigator# 130336	Erfurt
Germany	Site Reference ID/Investigator# 130334	Frankfurt am Main
Germany	Site Reference ID/Investigator# 130335	Munich
Hungary	Site Reference ID/Investigator# 128181	Budapest
Hungary	Site Reference ID/Investigator# 130338	Kiskunhalas
Hungary	Site Reference ID/Investigator# 128183	Kistarcsa
Hungary	Site Reference ID/Investigator# 128469	Szolnok
New Zealand	Site Reference ID/Investigator# 128184	Auckland
New Zealand	Site Reference ID/Investigator# 131589	Nelson
Poland	Site Reference ID/Investigator# 130392	Bialystok
Poland	Site Reference ID/Investigator# 137177	Bochnia
Poland	Site Reference ID/Investigator# 134449	Elblag
Poland	Site Reference ID/Investigator# 129337	Grodzisk Mazowiecki
Poland	Site Reference ID/Investigator# 130391	Katowice
Poland	Site Reference ID/Investigator# 134670	Lublin
Poland	Site Reference ID/Investigator# 128188	Oswiecim
Poland	Site Reference ID/Investigator# 129338	Poznan
Poland	Site Reference ID/Investigator# 130345	Stalowa Wola
Poland	Site Reference ID/Investigator# 128186	Torun
Poland	Site Reference ID/Investigator# 134448	Warsaw
Poland	Site Reference ID/Investigator# 129336	Wroclaw
Poland	Site Reference ID/Investigator# 130340	Wroclaw
Poland	Site Reference ID/Investigator# 136552	Wroclaw
Romania	Site Reference ID/Investigator# 128192	Bucharest
Romania	Site Reference ID/Investigator# 129775	Bucharest
Romania	Site Reference ID/Investigator# 129797	Bucharest
Romania	Site Reference ID/Investigator# 129795	Oradea
Romania	Site Reference ID/Investigator# 136634	Timisoara
United States	Site Reference ID/Investigator# 129181	Albuquerque	New Mexico
United States	Site Reference ID/Investigator# 129695	Austin	Texas
United States	Site Reference ID/Investigator# 130305	Charlotte	North Carolina
United States	Site Reference ID/Investigator# 129736	Franklin	Wisconsin
United States	Site Reference ID/Investigator# 136550	Frederick	Maryland
United States	Site Reference ID/Investigator# 137144	Gilbert	Arizona
United States	Site Reference ID/Investigator# 128101	Houston	Texas
United States	Site Reference ID/Investigator# 140197	Houston	Texas
United States	Site Reference ID/Investigator# 130060	Huntsville	Alabama
United States	Site Reference ID/Investigator# 128099	Jackson	Tennessee
United States	Site Reference ID/Investigator# 130279	Kalamazoo	Michigan
United States	Site Reference ID/Investigator# 128104	Lenexa	Kansas
United States	Site Reference ID/Investigator# 131570	Miami Lakes	Florida
United States	Site Reference ID/Investigator# 130350	Murrieta	California
United States	Site Reference ID/Investigator# 129182	Phoenix	Arizona
United States	Site Reference ID/Investigator# 129341	Raleigh	North Carolina
United States	Site Reference ID/Investigator# 130044	Salisbury	North Carolina
United States	Site Reference ID/Investigator# 128100	Worcester	Massachusetts
United States	Site Reference ID/Investigator# 129340	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in American College of Rheumatology Response Rate (ACR) 20	ACR criteria measures improvement in tender or swollen joint counts.	From Week 1 to Week 12	No
Secondary	Change in Disease Activity Score 28 (DAS28) high sensitivity C-Reactive Protein (hsCRP)	Determined by hsCRP lab test.	From Week 0 to Week 12	No
Secondary	Proportion of subjects achieving ACR50 responder status	ACR criteria measures improvement in tender or swollen joint counts.	At Week 12	No
Secondary	Proportion of subjects achieving Low Disease Activity (LDA)	Determined by disease activity score using 28 joint counts (DAS28) [CRP] or clinical disease activity index (CDAI) criteria.	At Week 12	No
Secondary	Proportion of subjects achieving Clinical Remission	Determined by Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) and Clinical Disease Activity Index (CDAI) criteria.	At Week 12	No
Secondary	Proportion of subjects achieving ACR70 responder status	ACR criteria measures improvement in tender or swollen joint counts.	At Week 12	No

External Links

•   Humira Prescribing info
•   Recruitment