NCT02384538

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled study to compare the safety and efficacy of ABT-981 to placebo in subjects with erosive hand osteoarthritis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_2

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

March 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
1 year until next milestone

Results Posted

Study results publicly available

July 13, 2017

Completed
Last Updated

August 11, 2017

Status Verified

July 1, 2017

Enrollment Period

1.3 years

First QC Date

March 5, 2015

Results QC Date

June 12, 2017

Last Update Submit

July 13, 2017

Conditions

Erosive Hand Osteoarthritis

Keywords

OsteoarthritisJoint diseasesMusculoskeletal diseasesRheumatic diseasesArthritisOsteoarthritis, Hand

Outcome Measures

Primary Outcomes (1)

  • Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Week 16

    The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The pain subdomain score ranges from 0 to 50; lower scores indicate better status. A decrease in the pain subdomain score represents improvement in status. Last Observation Carried Forward (LOCF): Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.

    Week 0 (Baseline), Week 16

Secondary Outcomes (6)

  • Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit

    Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26

  • Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit

    Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26

  • Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit

    Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26

  • Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit

    Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26

  • Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit

    Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26

  • +1 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.

Biological: Placebo for ABT-981

ABT-981

EXPERIMENTAL

ABT-981 200 mg every two weeks (Q2W) for 24 weeks.

Biological: ABT-981

Interventions

ABT-981BIOLOGICAL

ABT-981 administered by subcutaneous injection

Also known as: lutikizumab
ABT-981
Placebo for ABT-981BIOLOGICAL

Placebo for ABT-981 administered by subcutaneous injection

Placebo

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female between the ages of 35 to 80.
  • Must fulfill 1990 American College of Rheumatology (ACR) hand osteoarthritis (OA) criteria
  • Must have radiographic evidence of erosive hand OA
  • Have one or more clinical signs and symptoms of active inflammation in at least three hand joints
  • Subject Assessment of Hand Pain Intensity in at least one hand is ≥ 6.

You may not qualify if:

  • Previous exposure to any anti-interleukin-1 treatment, to corticosteroids within 1 month prior to Screening, to intra-articular hyaluronic acid injection into hand joint(s) within 6 months prior to Screening, to any immunosuppressive biologic therapy within 1 month or 5 half-lives (whichever is longer) prior to the first dose of study drug, OR current use of immunosuppressive oral medications within 3 months or 5 half-lives (whichever is longer) prior to the first dose of study drug.
  • Absolute neutrophil count \< 2,000 per mm3
  • Diagnosis of one or more of the following:
  • Fibromyalgia,
  • Inflammatory arthritis such as rheumatoid arthritis, peripheral seronegative spondyloarthropathy,
  • Psoriatic arthritis, psoriasis,
  • Microcrystalline (including gout and pseudo gout) arthritis affecting the hands,
  • Any OA of the hands due to an infectious origin or acute traumatic episode, secondary OA or OA linked to cartilage and bone dysplasia,
  • Other chronic painful syndromes that could interfere with assessment of pain at the hand(s).
  • Any uncontrolled medical illness or an unstable treatment or therapy.
  • Any reason that prohibits a subject to undergo an MRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kloppenburg M, Peterfy C, Haugen IK, Kroon F, Chen S, Wang L, Liu W, Levy G, Fleischmann RM, Berenbaum F, van der Heijde D, Bansal P, Wittoek R, Feng S, Fang Y, Saltarelli M, Medema JK, Levesque MC. Phase IIa, placebo-controlled, randomised study of lutikizumab, an anti-interleukin-1alpha and anti-interleukin-1beta dual variable domain immunoglobulin, in patients with erosive hand osteoarthritis. Ann Rheum Dis. 2019 Mar;78(3):413-420. doi: 10.1136/annrheumdis-2018-213336. Epub 2018 Dec 14.

    PMID: 30552176DERIVED

MeSH Terms

Conditions

OsteoarthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesArthritis

Interventions

lutikizumab

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie
800-633-9110

Study Officials

  • AbbVie Inc

    AbbVie

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2015

First Posted

March 10, 2015

Study Start

March 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 11, 2017

Results First Posted

July 13, 2017

Record last verified: 2017-07