NCT02531178

Brief Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose study designed to assess the safety, tolerability, pharmacokinetics, and immunogenicity of different dose levels of ABBV-257 given with methotrexate. ABBV-257 or placebo will be administered once every other week (EOW) for a total of 4 doses. Subjects will continue on their stable dose of methotrexate weekly throughout participation in the study. This study will be conducted in approximately 24 subjects in 3 dose groups, with 8 subjects per group. Within each group, 6 subjects will be randomized to receive ABBV-257 and 2 subjects will receive placebo. Subjects participating in one dose group will be ineligible to participate in another dose group in the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_1 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 24, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

7 months

First QC Date

July 14, 2015

Last Update Submit

March 1, 2016

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (6)

  • Proportion of subjects with adverse events

    This will be collected through out the study

    Up to day 193

  • Change in Vital signs

    Vital signs including blood pressure and heart rate will be assessed

    From day 1 to day 193

  • Change in Physical examination

    Changes in any physical exam assessed by the physician will be assessed.

    From day 1 to day 193

  • Changes in Electrocardiogram (ECG)

    ECG measurements will be assessed

    From day 1 to day 193

  • Maximum observed serum concentration (Cmax)

    This will be assessed using non-compartmental methods.

    Up to day 50

  • Time to maximum observed serum concentration (Tmax)

    This will be assessed using non-compartmental methods.

    Up to day 50

Secondary Outcomes (1)

  • Immunogenicity by measurement of Anti-drug antibody

    Up to day 193

Other Outcomes (4)

  • American College of Rheumatology (ACR) 20 response rate

    Up to day 193

  • American College of Rheumatology (ACR) 50 response rate

    Up to day 193

  • American College of Rheumatology (ACR) 70 response rate

    Up to day 193

  • +1 more other outcomes

Study Arms (3)

low dose ABBV-257

EXPERIMENTAL

Low dose every other week (eow), Weeks 0-8

Biological: ABBV-257Biological: Placebo

Medium dose of ABBV-257

EXPERIMENTAL

Medium dose every other week (eow), Weeks 0-8

Biological: ABBV-257Biological: Placebo

high dose of ABBV-257

EXPERIMENTAL

high dose every other week (eow), Weeks 0-8

Biological: ABBV-257Biological: Placebo

Interventions

ABBV-257BIOLOGICAL

subcutaneous injection

Medium dose of ABBV-257high dose of ABBV-257low dose ABBV-257
PlaceboBIOLOGICAL

Placebo for ABBV-257

Medium dose of ABBV-257high dose of ABBV-257low dose ABBV-257

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Rheumatoid Arthritis based on the 2010 American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) criteria, or ACR 1987 for patients with diagnosis prior 2011 ≥ 3 months.
  • Except for methotrexate (MTX), the subject must have discontinued all disease modifying anti-rheumatic drugs (DMARD) for at least 5 half-lives before the first dose of study drug, and undergone cholestyramine washout if received Leflunomide within the past 3 months.
  • Subject must have been on MTX therapy \> 3 months and on a stable dose (7.5 - 25 mg/week), for at least 4 weeks prior to the first dose of study drug. Subject must be able to continue on stable dose of MTX for the duration of study participation.
  • Body Mass Index (BMI) is 19 to 35, inclusive. (BMI is calculated as weight \[kg\] divided by height \[m2\].)
  • Judged to be in good general health as determined by the Investigator based upon the results of medical history, laboratory profile, physical examination and 12-lead electrocardiogram (ECG) performed at screening

You may not qualify if:

  • Evidence of anti-ABBV-257 antibody results in a pre-study serum sample.
  • History of significant allergic reaction or significant sensitivity to any constituents of the study drug; or history of anaphylactic reaction to any agent (e.g., food products and bee sting); or history of a major reaction to any Immunoglobulin G (IgG) containing product.
  • History of persistent chronic or active infection(s) requiring hospitalization or treatment with intravenous or oral antimicrobials/antibiotics within 30 days prior to initial study drug administration.
  • History or evidence of active tuberculosis (TB) or the subject has evidence of risk factor for latent TB.
  • Clinically significant abnormal screening laboratory results as evaluated by the Investigator, including serum values of Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) greater than 2.25 × the upper limit of normal, or creatinine greater than 1.5 × the upper limit of normal, or absolute neutrophil count \< 1500 μ/L.
  • Subject has any medical condition or illness other than RA that is not well controlled with treatment that would, in the opinion of the investigator, preclude study participation or interfere with other symptoms of Rheumatoid Arthritis (RA).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site Reference ID/Investigator# 139394

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Heikki Mansikka, PhD

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2015

First Posted

August 24, 2015

Study Start

July 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 3, 2016

Record last verified: 2016-03

Locations

DE(1)