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

September 22, 2016 updated by: AbbVie

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

222

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Adalimumab 40 mg EOW
Adalimumab 40 mg every other week (EOW) for 11 weeks.
Biological: adalimumab
adalimumab administered as subcutaneous injection every other week (EOW)
Other Names:
  • Humira
Experimental: ABT-122 60 mg EOW
ABT-122 60 mg every other week (EOW) for 11 weeks.
Biological: ABT-122
ABT-122 administered as subcutaneous injection every other week (EOW)
Experimental: ABT-122 120 mg EOW
ABT-122 120 mg every other week (EOW) for 11 weeks.
Biological: ABT-122
ABT-122 administered as subcutaneous injection every other week (EOW)
Experimental: ABT-122 120 mg EW
ABT-122 120 mg every week (EW) for 11 weeks.
Biological: ABT-122
ABT-122 administered as subcutaneous injection every other week (EOW)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Time Frame: Baseline (Day 1) and 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Disease Activity Score 28 With High Sensitivity C-Reactive Protein (DAS28 [hsCRP])
Time Frame: Baseline, Weeks 2, 4, 6, 8, and 12
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10: a score >5.1 indicates high disease activity, a score <3.2 indicates low disease activity, and a score <2.6 indicates clinical remission. A negative change from baseline represents improvement. n=the number of participants with evaluable data at each time point. LOCF was used (only post-baseline values were carried forward).
Baseline, Weeks 2, 4, 6, 8, and 12
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 12
Time Frame: Baseline (Day 1) and Week 12
Response defined as at least 50% 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, PtGA; PGA, HAQ-DI, and hsCRP. LOCF was used (only post-baseline values were carried forward).
Baseline (Day 1) and Week 12
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12
Time Frame: Baseline (Day 1) and Week 12
Response defined as at least 70% 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, PtGA; PGA, HAQ-DI, and hsCRP. LOCF was used (only post-baseline values were carried forward).
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
Time Frame: Week 12
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10: a score >5.1 indicates high disease activity, a score <3.2 indicates low disease activity, and a score <2.6 indicates clinical remission. LDA is defined as a DAS28 (hsCRP) score from 2.6 to < 3.2 at Week 12. CR is defined as a DAS28 (hsCRP) score < 2.6 at Week 12. LOCF was used (only post-baseline values were carried forward).
Week 12
Percentage of Participants Achieving CR Based on DAS28 (hsCRP) at Week 12
Time Frame: Week 12
The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10: a score >5.1 indicates high disease activity, a score <3.2 indicates low disease activity, and a score <2.6 indicates clinical remission. CR is defined as a DAS28 (hsCRP) score < 2.6 at Week 12. LOCF was used (only post-baseline values were carried forward).
Week 12
Percentage of Participants Achieving LDA or CR Based on Clinical Disease Activity Index (CDAI) at Week 12
Time Frame: Week 12
The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA is defined as a CDAI score from 2.8 to ≤ 10 at Week 12. CR is defined as a CDAI score ≤ 2.8 at Week 12. LOCF was used (only post-baseline values were carried forward).
Week 12
Percentage of Participants Achieving CR Based on Clinical Disease Activity Index (CDAI) at Week 12
Time Frame: Week 12
The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. CR is defined as a CDAI score ≤ 2.8 at Week 12. LOCF was used (only post-baseline values were carried forward).
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: Heikki Mansikka, MD, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

May 16, 2014

First Submitted That Met QC Criteria

May 16, 2014

First Posted (Estimate)

May 20, 2014

Study Record Updates

Last Update Posted (Estimate)

November 11, 2016

Last Update Submitted That Met QC Criteria

September 22, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M12-963
  • 2013-004019-37 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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