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

• Register: EUCTR
• Last refreshed on: 17 January 2022
• Main ID: EUCTR2013-004019-37-RO
• Date of registration: 05/03/2015
• Prospective Registration: No
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public 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
• 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: 22/10/2014
• Target sample size: 160
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004019-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd

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. RA diagnosis at least 3 months from the date of first Screening.
4. Documented positive Rheumatoid Factor (RF) or Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody levels prior to or at Screening:
• If RF and Anti-CCP Antibody tests are negative, documented evidence of prior erosions on radiographs or CT/MRI of hands is an acceptable alternative for meeting this inclusion criterion.
5. Have active RA defined by minimum disease activity criteria:
• = 6 Swollen joints (based on 66 joint counts) at Screening,
• = 6 Tender joints (based on 68 joint counts) at Screening,
• hsCRP > Upper limit of normal at Screening.
6. Inadequate response to 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 = 10 mg/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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 104
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56

Exclusion criteria:
1. Subject has previous exposure to Humira, other TNF inhibitors or other biological DMARDs.
2. Current treatment with traditional oral 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 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 /mm3,
• AST or 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] (109/L),
• Clinically significant abnormal screening laboratory results as evaluated by the Investigator.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Rheumatoid Arthritis
MedDRA version: 17.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Product Name: ABT-122
Product Code: ABT-122
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: na
Other descriptive name: ABT-122
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Lyophilisate for solution for injection
Route of administration of the placebo: Subcutaneous use

Trade Name: Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe
Product Name: ADALIMUMAB
Product Code: 331731-18-1
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: Humira
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: The primary objective is to estimate the treatment effect of ABT-122 by measuring the percentage of subjects achieving American College of Rheumatology response rates (ACR20) at Week 12 and to assess the safety and tolerability of ABT-122 in subjects with active rheumatoid arthritis (RA).

Timepoint(s) of evaluation of this end point: Week 12

Primary end point(s): ACR20 response rate at Week 12. ACR20 response rate will be determined based on 20% or greater improvement in Tender Joint Count (TJC) and Swollen Joint Count (SJC) and = 3 of the 5 measures of Patient's Assessment of Pain (VAS), Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire Disability Index (HAQ-DI) and hsCRP.

Secondary Objective: ? Change from Baseline in DAS28 [hsCRP] at Weeks 2, 4, 6, 8, and 12.
? Proportion of subjects achieving ACR50 and ACR70 responder status at Week 12.
? Proportion of subjects achieving Low Disease Activity (LDA) or Clinical Remission (CR) based on DAS28 [hsCRP] and CDAI criteria at Week 12.
? Proportion of subjects achieving CR based on DAS28 [hsCRP] and CDAI criteria at Week 12.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 12

Secondary end point(s): • Change from Baseline in DAS28 [hsCRP] at Weeks 2, 4, 6, 8, and 12.
• Proportion of subjects achieving ACR50 and ACR70 responder status at Week 12.
• Proportion of subjects achieving Low Disease Activity (LDA) or Clinical Remission (CR) based on DAS28 [hsCRP] and CDAI criteria at Week 12.
• Proportion of subjects achieving Clinical Remission based on DAS28 [hsCRP] and CDAI criteria at Week 12.

Secondary ID(s)

M12-963

2013-004019-37-DE

Source(s) of Monetary Support

Abbvie Inc

Ethics review

Status: Approved
Approval date: 22/10/2014
Contact:

Results

• Results available: Yes
• Date Posted: 26/11/2016
• Date Completed: 01/10/2015
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-004019-37/results