Adult male and female patients with erosive hand osteoarthritis MedDRA version: 18.1 Level: LLT Classification code 10019115 Term: Hand osteoarthritis System Organ Class: 100000004859
Conditions
Interventions
Product Name: ABT-981
Product Code: ABT-981
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: na
Other descriptive name: ABT-981
Concentration unit: mg/ml milligram(s)/
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female between the ages of 35 to 80 years (inclusive) 2. Must fulfill 1990 American College of Rheumatology (ACR) hand OA criteria, defined as hand pain, aching, or stiffness and three or four of the following features: •hard tissue enlargement of two or more of the following 10 selected joints: the second and third distal interphalangeal (DIP) joint of both hands, the second and third proximal interphalangeal (PIP) joints of both hands, the first carpometacarpal (CMC) joints of both hands, •hard tissue enlargement of two or more DIP joints, •fewer than three swollen metacarpophalangeal (MCP) joints, and •deformity of at least one of the 10 selected joints. 3. Must have radiographic evidence of erosive hand OA with evidence of an "E" (erosive) or "E/R" (erosive with remodeling) joint as defined by Verbruggen and colleagues in at least one of the hand interphalangeal joints based on hand x-rays obtained during the Screening Period or within 3 months of the Screening Visit 4. Have one or more clinical signs and symptoms of active inflammation in at least three hand joints, with active inflammation defined as localized tenderness and/or soft tissue swelling at Screening and Day 1 Visit. 5. Subject Assessment of Hand Pain Intensity in at least one hand is = 6 (11-point Numeric Rating Scale [NRS-11]) at Screening and Day 1 Visit. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Previous exposure to any anti-IL-1 treatment including (and not limited to) anakinra, canakinumab and rilonacept OR one or more of the following: •Oral, intramuscular (IM), intravenous (IV), epidural or intra-articular corticosteroids within 1 month prior to Screening, •Intra-articular hyaluronic acid injection into hand joint(s) within 6 months prior to Screening, •Any investigational drug product of chemical or biologic nature within 1 month or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug, •Any immunosuppressive biologic therapy including (and not limited to), etanercept, adalimumab, infliximab, golimumab, certolizumab, abatacept, tocilizumab, natalizumab, efalizumab, ustekinumab, belimumab or rituximab within 1 month or 5 half-lives (whichever is longer) prior to the first dose of study drug, •Current use of immunosuppressive oral medications including (and not limited to) Tofacitinib, hydroxychloroquine, azathioprine, methotrexate, leflunomide, mycophenolate, sulfasalazine, gold, cyclophosphamide, penicillamine and/or tacrolimus, or tetracycline based agents within 3 months or 5 half-lives (whichever is longer) prior to the first dose of study drug, •Colchicine within 1 month prior to the first dose of study drug, •Vaccination with a live viral agent (including live attenuated influenza vaccine via nasal spray) = 30 day prior to Screening Visit through 10 weeks (5 × the half-life of ABT-981) after the last dose of study drug. 2. Absolute neutrophil count (ANC) 470 msec in females or > 450 msec in males or PR interval > 220 msec. 6. Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) within the past 5 years 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 within 1 month prior to the first dose of study drug. 8. Any reason that prohibits a subject to undergo an MRI (e.g., pacemaker, certain types of metal implants, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the effect of ABT-981 on pain using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN NR3.1) pain subdomain score, in subjects with erosive hand OA at Week 16.;Secondary Objective: ? Evaluate the safety and tolerability of ABT-981 in subjects with erosive hand OA throughout the study. ? Evaluate the effect of ABT-981 on AUSCAN NR3.1 total and individual subdomain (pain, physical function and stiffness) scores of erosive hand OA throughout the study. ? Evaluate the effect of ABT-981 on Subject Assessment of Hand Pain Intensity via an 11-point Numeric Rating Scale (NRS-11) throughout the study. ? Evaluate the effect of ABT-981 on Patient Global Assessment (PGA) of Hand Arthritis Status using a NRS-11 throughout the study. ? Evaluate the PK and ADA levels of ABT-981. ;Primary end point(s): The primary efficacy variables will be the changes from Baseline to Week 16 in AUSCAN NR3.1 pain subdomain score. ;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints including change in total AUSCAN score and individual subdomain (pain, physical function and stiffness) scores from Baseline, change of patient index hand resting pain from Baseline using NRS-11, and change of Patient Global Assessment of Arthritis from Baseline using NRS-11 will be analyzed similarly at Week 16. ;Timepoint(s) of evaluation of this end point: Weeks 16 | — |
Countries
Belgium, Denmark, France, Netherlands, Switzerland, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
Abbvie Ltd
Outcome results
None listed