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A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABBV-257 in Subjects With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT02531178
Recruitment Status : Completed
First Posted : August 24, 2015
Last Update Posted : March 3, 2016
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: ABBV-257 Biological: Placebo Phase 1

Detailed Description:
Multiple dose study designed to assess the safety, tolerability, pharmacokinetics, and immunogenicity of different dose levels of ABBV-257 given with methotrexate.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ABBV-257
Study Start Date : July 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: low dose ABBV-257
Low dose every other week (eow), Weeks 0-8
Biological: ABBV-257
subcutaneous injection

Biological: Placebo
Placebo for ABBV-257

Experimental: Medium dose of ABBV-257
Medium dose every other week (eow), Weeks 0-8
Biological: ABBV-257
subcutaneous injection

Biological: Placebo
Placebo for ABBV-257

Experimental: high dose of ABBV-257
high dose every other week (eow), Weeks 0-8
Biological: ABBV-257
subcutaneous injection

Biological: Placebo
Placebo for ABBV-257




Primary Outcome Measures :
  1. Proportion of subjects with adverse events [ Time Frame: Up to day 193 ]
    This will be collected through out the study

  2. Change in Vital signs [ Time Frame: From day 1 to day 193 ]
    Vital signs including blood pressure and heart rate will be assessed

  3. Change in Physical examination [ Time Frame: From day 1 to day 193 ]
    Changes in any physical exam assessed by the physician will be assessed.

  4. Changes in Electrocardiogram (ECG) [ Time Frame: From day 1 to day 193 ]
    ECG measurements will be assessed

  5. Maximum observed serum concentration (Cmax) [ Time Frame: Up to day 50 ]
    This will be assessed using non-compartmental methods.

  6. Time to maximum observed serum concentration (Tmax) [ Time Frame: Up to day 50 ]
    This will be assessed using non-compartmental methods.


Secondary Outcome Measures :
  1. Immunogenicity by measurement of Anti-drug antibody [ Time Frame: Up to day 193 ]
    Immunogenicity will be measured to see if the body has produced an immune response to ABBV-257


Other Outcome Measures:
  1. American College of Rheumatology (ACR) 20 response rate [ Time Frame: Up to day 193 ]
    ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.

  2. American College of Rheumatology (ACR) 50 response rate [ Time Frame: Up to day 193 ]
    ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.

  3. American College of Rheumatology (ACR) 70 response rate [ Time Frame: Up to day 193 ]
    ACR criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.

  4. Change in Disease Activity Score 28 [ Time Frame: From day 1 to day 193 ]
    Calculated from tender joint, swollen joint and high sensitive C-reactive protein



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531178


Locations
Germany
Site Reference ID/Investigator# 139394
Berlin, Germany, 10117
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Heikki Mansikka, PhD AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02531178     History of Changes
Other Study ID Numbers: M14-439
2015-000094-12 ( EudraCT Number )
First Posted: August 24, 2015    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: March 2016

Keywords provided by AbbVie:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases