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

Hand Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02384538
• Other study ID #: M14-171
• Secondary ID: 2014-001096-31
• Status: Completed
• Phase: Phase 2
• First received: March 5, 2015
• Last updated: July 15, 2016
• Start date: July 2013
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Denmark: Danish Health and Medicines AuthorityBelgium: Federal Agency for Medicines and Health Products, FAMHPSwitzerland: SwissmedicFrance: Agence Nationale de Sécurité du Médicament et des produits de santéUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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 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. Clinically significant cardiac disease.

6. Evidence of dysplasia or history of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.

7. History of persistent chronic or active infection(s) requiring hospitalization or treatment with antimicrobials/antibiotics.

8. Any reason that prohibits a subject to undergo an MRI.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hand Osteoarthritis
• Osteoarthritis

Intervention

Biological:
• ABT-981
ABT-981

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Belgium	Site Reference ID/Investigator# 133874	Anderlecht
Belgium	Site Reference ID/Investigator# 133873	Genk
Belgium	Site Reference ID/Investigator# 133872	Ghent
Belgium	Site Reference ID/Investigator# 133871	Leuven
Belgium	Site Reference ID/Investigator# 133869	Liege
Denmark	Site Reference ID/Investigator# 132908	Aarhus C
Denmark	Site Reference ID/Investigator# 132906	Frederiksberg
Denmark	Site Reference ID/Investigator# 132910	Hjoerring
Denmark	Site Reference ID/Investigator# 132911	Vejle
France	Site Reference ID/Investigator# 133880	Bordeaux Cedex
France	Site Reference ID/Investigator# 133875	Paris
France	Site Reference ID/Investigator# 133878	Vandoeuvre les Nancy
Netherlands	Site Reference ID/Investigator# 133970	Leiden
Netherlands	Site Reference ID/Investigator# 135388	Nijmegen
Netherlands	Site Reference ID/Investigator# 133973	Utrecht
Switzerland	Site Reference ID/Investigator# 133975	Basel
Switzerland	Site Reference ID/Investigator# 133977	Zurich
United States	Site Reference ID/Investigator# 133362	Birmingham	Alabama
United States	Site Reference ID/Investigator# 135815	Boston	Massachusetts
United States	Site Reference ID/Investigator# 134429	Charlottesville	Virginia
United States	Site Reference ID/Investigator# 133355	Chicago	Illinois
United States	Site Reference ID/Investigator# 134209	Cincinnati	Ohio
United States	Site Reference ID/Investigator# 133670	Clearwater	Florida
United States	Site Reference ID/Investigator# 135376	Clifton	New Jersey
United States	Site Reference ID/Investigator# 133324	Dallas	Texas
United States	Site Reference ID/Investigator# 133333	Dallas	Texas
United States	Site Reference ID/Investigator# 134801	Denver	Colorado
United States	Site Reference ID/Investigator# 134590	Duncansville	Pennsylvania
United States	Site Reference ID/Investigator# 135280	Edgewater	Florida
United States	Site Reference ID/Investigator# 134591	El Cajon	California
United States	Site Reference ID/Investigator# 133332	Honolulu	Hawaii
United States	Site Reference ID/Investigator# 134748	Huntsville	Alabama
United States	Site Reference ID/Investigator# 134211	Mesa	Arizona
United States	Site Reference ID/Investigator# 134030	Miami	Florida
United States	Site Reference ID/Investigator# 134031	New Port Richey	Florida
United States	Site Reference ID/Investigator# 133354	New York	New York
United States	Site Reference ID/Investigator# 134430	Newport News	Virginia
United States	Site Reference ID/Investigator# 133323	Ocala	Florida
United States	Site Reference ID/Investigator# 133336	Palo Alto	California
United States	Site Reference ID/Investigator# 134592	Phoenix	Arizona
United States	Site Reference ID/Investigator# 133347	Sacramento	California
United States	Site Reference ID/Investigator# 134208	Santa Ana	California
United States	Site Reference ID/Investigator# 135818	Santa Monica	California
United States	Site Reference ID/Investigator# 133350	Seattle	Washington
United States	Site Reference ID/Investigator# 133341	Trumbull	Connecticut
United States	Site Reference ID/Investigator# 133346	Tucson	Arizona
United States	Site Reference ID/Investigator# 133320	Wheaton	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  France,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain as assessed by the Australian/Canadian Osteoarthritis Hand Index (AUSCAN NR3.1) pain subdomain score	The AUSCAN NR3.1 will be used to measure the pain subdomain score.	From Week 0 to Week 16	No
Secondary	Change in AUSCAN NR3.1 total scores of erosive hand osteoarthritis	The AUSCAN questionnaire is a 15 item questionnaire assessing the three dimensions of pain, disability and joint stiffness.	From Week 0 through Week 26	No
Secondary	Change of subject index hand resting pain	The Subject Assessment of Hand Pain Intensity questionnaire [11 point numeric rating scale (NRS-11)] will be used.	From Week 0 to Week 26	No
Secondary	Change of patient global assessment of arthritis	The Patient Global Assessment of Hand Osteoarthritis questionnaire [11 point numeric rating scale (NRS-11)] will be used.	From Week 0 to Week 26	No
Secondary	Change in AUSCAN NR3.1 individual subdomain (pain, physical function and stiffness) scores of erosive hand osteoarthritis	The AUSCAN questionnaire is a 15 item questionnaire assessing the three dimensions of pain, disability and joint stiffness.	From Week 0 through Week 26	No