Erosive Hand Osteoarthritis
Conditions
Keywords
Osteoarthritis, Joint diseases, Musculoskeletal diseases, Rheumatic diseases, Arthritis, Osteoarthritis, Hand
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.
Interventions
BIOLOGICALABT-981
ABT-981 administered by subcutaneous injection
BIOLOGICALPlacebo for ABT-981
Placebo for ABT-981 administered by subcutaneous injection
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Week 16 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit | 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. |
| 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 | 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. |
Participant flow
Pre-assignment details
A total of 132 participants were randomized; 1 participant who was randomized to the ABT-981 treatment group did not receive a dose of study drug and was excluded from the analyses, for a total of 131 participants in the modified intent-to-treat population (mITT).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo for ABT-981 every two weeks (Q2W) for 24 weeks. | 67 |
| ABT-981 ABT-981 200 mg every two weeks (Q2W) for 24 weeks. | 64 |
| Total | 131 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 4 |
| Overall Study | Lack of Efficacy | 4 | 4 |
| Overall Study | Other | 1 | 3 |
| Overall Study | Withdrew Consent | 0 | 4 |
Baseline characteristics
| Characteristic | Placebo | ABT-981 | Total |
|---|---|---|---|
| Age, Continuous | 65.8 years STANDARD_DEVIATION 7.325 | 65.7 years STANDARD_DEVIATION 8.132 | 65.7 years STANDARD_DEVIATION 7.7 |
| Sex: Female, Male Female | 58 Participants | 53 Participants | 111 Participants |
| Sex: Female, Male Male | 9 Participants | 11 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 45 / 67 | 49 / 64 |
| serious Total, serious adverse events | 2 / 67 | 2 / 64 |
Outcome results
Primary
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.
Time frame: Week 0 (Baseline), Week 16
Population: mITT population: all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Week 16 | -10.74 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Week 16 | -9.22 units on a scale |
p-value: 0.38695% CI: [-1.944, 4.99]ANCOVA
Secondary
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit
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.
Time frame: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26
Population: All participants in the mITT population.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit | Week 8 | -8.90 units on a scale |
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit | Week 16 | -10.74 units on a scale |
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit | Week 4 | -5.01 units on a scale |
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit | Week 20 | -7.28 units on a scale |
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit | Week 12 | -8.31 units on a scale |
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit | Week 26 | -8.76 units on a scale |
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit | Week 2 | -3.25 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit | Week 26 | -10.37 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit | Week 2 | -3.27 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit | Week 4 | -4.26 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit | Week 8 | -6.44 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit | Week 12 | -5.64 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit | Week 16 | -9.22 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit | Week 20 | -8.37 units on a scale |
Secondary
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit
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.
Time frame: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26
Population: All participants in the mITT population.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit | Week 8 | -14.25 units on a scale |
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit | Week 16 | -17.18 units on a scale |
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit | Week 4 | -8.43 units on a scale |
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit | Week 20 | -11.50 units on a scale |
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit | Week 12 | -12.54 units on a scale |
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit | Week 26 | -14.25 units on a scale |
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit | Week 2 | -6.23 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit | Week 26 | -16.39 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit | Week 2 | -4.79 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit | Week 4 | -7.04 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit | Week 8 | -8.97 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit | Week 12 | -8.53 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit | Week 16 | -14.64 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit | Week 20 | -12.53 units on a scale |
Comparison: Week 16p-value: 0.38395% CI: [-3.214, 8.308]ANCOVA
Secondary
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit
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.
Time frame: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26
Population: All participants in the mITT population.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit | Week 8 | -1.51 units on a scale |
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit | Week 16 | -1.76 units on a scale |
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit | Week 4 | -0.98 units on a scale |
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit | Week 20 | -1.34 units on a scale |
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit | Week 12 | -1.65 units on a scale |
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit | Week 26 | -1.94 units on a scale |
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit | Week 2 | -0.74 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit | Week 26 | -2.45 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit | Week 2 | -0.96 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit | Week 4 | -1.24 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit | Week 8 | -1.43 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit | Week 12 | -1.23 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit | Week 16 | -1.61 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit | Week 20 | -1.85 units on a scale |
Comparison: Week 16p-value: 0.71995% CI: [-0.677, 0.979]ANCOVA
Secondary
Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit
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.
Time frame: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26
Population: All participants in the mITT population.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit | Week 8 | -24.52 units on a scale |
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit | Week 16 | -29.37 units on a scale |
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit | Week 4 | -14.06 units on a scale |
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit | Week 20 | -19.68 units on a scale |
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit | Week 12 | -22.29 units on a scale |
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit | Week 26 | -24.73 units on a scale |
| Placebo | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit | Week 2 | -10.01 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit | Week 26 | -28.99 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit | Week 2 | -8.85 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit | Week 4 | -12.18 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit | Week 8 | -16.65 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit | Week 12 | -15.15 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit | Week 16 | -25.12 units on a scale |
| ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit | Week 20 | -22.33 units on a scale |
Comparison: Week 16p-value: 0.38795% CI: [-5.448, 13.945]ANCOVA
Secondary
Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit
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.
Time frame: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26
Population: All participants in the mITT population.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit | Week 8 | -2.40 units on a scale |
| Placebo | Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit | Week 16 | -2.05 units on a scale |
| Placebo | Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit | Week 2 | -0.62 units on a scale |
| Placebo | Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit | Week 20 | -1.61 units on a scale |
| Placebo | Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit | Week 12 | -1.65 units on a scale |
| Placebo | Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit | Week 26 | -2.02 units on a scale |
| Placebo | Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit | Week 4 | -1.18 units on a scale |
| ABT-981 | Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit | Week 26 | -2.52 units on a scale |
| ABT-981 | Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit | Week 2 | -0.69 units on a scale |
| ABT-981 | Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit | Week 4 | -1.06 units on a scale |
| ABT-981 | Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit | Week 8 | -1.74 units on a scale |
| ABT-981 | Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit | Week 12 | -0.81 units on a scale |
| ABT-981 | Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit | Week 16 | -1.60 units on a scale |
| ABT-981 | Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit | Week 20 | -1.75 units on a scale |
Comparison: Week 16p-value: 0.28195% CI: [-0.373, 1.272]ANCOVA
Secondary
Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit
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.
Time frame: Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26
Population: All participants in the mITT population.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit | Week 8 | -1.85 units on a scale |
| Placebo | Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit | Week 16 | -2.20 units on a scale |
| Placebo | Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit | Week 4 | -1.31 units on a scale |
| Placebo | Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit | Week 20 | -1.73 units on a scale |
| Placebo | Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit | Week 12 | -1.78 units on a scale |
| Placebo | Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit | Week 26 | -2.00 units on a scale |
| Placebo | Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit | Week 2 | -0.52 units on a scale |
| ABT-981 | Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit | Week 26 | -2.35 units on a scale |
| ABT-981 | Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit | Week 2 | -0.54 units on a scale |
| ABT-981 | Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit | Week 4 | -1.13 units on a scale |
| ABT-981 | Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit | Week 8 | -1.20 units on a scale |
| ABT-981 | Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit | Week 12 | -1.17 units on a scale |
| ABT-981 | Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit | Week 16 | -1.69 units on a scale |
| ABT-981 | Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit | Week 20 | -1.77 units on a scale |
Comparison: Week 16p-value: 0.21295% CI: [-0.3, 1.336]ANCOVA