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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


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
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