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A Phase 2a Study Evaluating the Safety and Efficacy of ABT-981 in Patients With Erosive Hand Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02384538
Recruitment Status : Completed
First Posted : March 10, 2015
Results First Posted : July 13, 2017
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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.

Condition or disease Intervention/treatment Phase
Erosive Hand Osteoarthritis Biological: ABT-981 Biological: Placebo for ABT-981 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-981 to Placebo in Subjects With Erosive Hand Osteoarthritis
Actual Study Start Date : March 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
 Biological: Placebo for ABT-981
Placebo for ABT-981 administered by subcutaneous injection
Experimental: ABT-981
ABT-981 200 mg every two weeks (Q2W) for 24 weeks.
 Biological: ABT-981
ABT-981 administered by subcutaneous injection
Other Name: lutikizumab


Outcome Measures
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Primary Outcome Measures :
  1. Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Week 16 [ Time Frame: Week 0 (Baseline), 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.


Secondary Outcome Measures :
  1. Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit [ Time Frame: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26 ]
    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. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.

  2. Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit [ Time Frame: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26 ]
    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 physical function subdomain score ranges from 0 to 90; lower scores indicate better status. A decrease in the physical function subdomain score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.

  3. Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit [ Time Frame: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26 ]
    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 stiffness subdomain score ranges from 0 to 10; lower scores indicate better status. A decrease in the stiffness subdomain score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.

  4. Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit [ Time Frame: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26 ]
    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 total score ranges from 0 to 150; lower scores indicate better status. A decrease in the total score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.

  5. Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit [ Time Frame: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26 ]
    Participants rated the pain intensity of each hand during the previous 48 hours using an 11-point scale (NRS-11). The change from baseline to each visit in NRS-11 in the index hand (the hand with the most disease) are presented. Scores range from 0 to 10 points, with higher scores indicating greater pain intensity. A decrease in the NRS-11 score represents a decrease in pain intensity.

  6. Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit [ Time Frame: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26 ]
    Participants were asked how much they were affected by hand OA by responding to the question "Considering all the ways your hand OA affects you, how have you been during the last 48 hours?" using an 11-point scale (NRS-11). Scores range from 0 to 10 points, with higher scores indicating greater effect of hand OA on the participant. A decrease in the NRS-11 score represents an improvement the effect of hand OA on the participant.


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Absolute neutrophil count < 2,000 per mm3

  3. 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).
  4. Any uncontrolled medical illness or an unstable treatment or therapy.
  5. Any reason that prohibits a subject to undergo an MRI.
Contacts and Locations
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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): NCT02384538


Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc AbbVie
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02384538    
Other Study ID Numbers: M14-171
2014-001096-31 ( EudraCT Number )
First Posted: March 10, 2015    Key Record Dates
Results First Posted: July 13, 2017
Last Update Posted: August 11, 2017
Last Verified: July 2017
Keywords provided by AbbVie:
Osteoarthritis
Joint diseases
Musculoskeletal diseases
 Rheumatic diseases
Arthritis
Osteoarthritis, Hand
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases