Erosive Hand OsteoarthritisPhase 2NCT02384538

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

A Phase 2 study testing ABT-981 in people with Erosive Hand Osteoarthritis, run by AbbVie.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 35 to 80 years
Conditions the study is for: Erosive Hand Osteoarthritis
What is being tested?: ABT-981
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 132 participants
Where: No sites listed yet
Study dates: Mar 2015to Jul 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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,

Show all 11Show fewer

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.

About this study

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

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.

Conditions: Erosive Hand Osteoarthritis
Being tested: ABT-981, Placebo for ABT-981
Keywords: Osteoarthritis, Joint diseases, Musculoskeletal diseases, Rheumatic diseases, Arthritis, Osteoarthritis, Hand
Medical subject headings: Osteoarthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Arthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABT-981Biological
Also called lutikizumab
ABT-981 administered by subcutaneous injection
Placebo for ABT-981Biological
Placebo for ABT-981 administered by subcutaneous injection

Study groups in NCT02384538
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo for ABT-981 every two weeks (Q2W) for 24 weeks. Receives: Biological: Placebo for ABT-981
ABT-981	Experimental	ABT-981 200 mg every two weeks (Q2W) for 24 weeks. Receives: Biological: ABT-981

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2015Jul 2016

First posted10 Mar 2015 (estimated)
Study startMar 2015
Primary completionJul 2016
Study completionJul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Erosive Hand OsteoarthritisStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 132 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02384538
Sponsor's protocol ID: M14-171
Other IDs: 2014-001096-31, 2014
Status last verified: Jul 2017
First submitted: 5 Mar 2015
Last updated: 11 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 30552176

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 2/3
Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments
Erosive Hand Osteoarthritis
Active, not recruitingPhase 4
Methotrexate in Erosive Inflammatory Hand Osteoarthritis
Hand Osteoarthritis, Erosive Osteoarthritis
Enrolling by invitationObservational study
A 30-month Follow-up of MERINO Participants to Evaluate Long-term Effects of Methotrexate in Erosive Hand OA.
Hand Osteoarthritis, Erosive Osteoarthritis
Active, not recruiting
DIGItal Cohort Osteoarthritis Design
Arthrosis of Hand

All Erosive Hand Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02384538
Acronym / sponsor ID: M14-171
Conditions: Erosive Hand Osteoarthritis
Keywords: Osteoarthritis, Joint diseases, Musculoskeletal diseases, Rheumatic diseases, Arthritis, Osteoarthritis, Hand
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 132 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: Mar 2015 (actual)
Primary completion: Jul 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 10 Mar 2015 (estimated)
Results: Posted 13 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Biological: Placebo for ABT-981Placebo for ABT-981 every two weeks (Q2W) for 24 weeks.
ABT-981	Experimental	Biological: ABT-981ABT-981 200 mg every two weeks (Q2W) for 24 weeks.

Who may qualify

Ages: 35 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (11 listed)

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:
Any uncontrolled medical illness or an unstable treatment or therapy.
Any reason that prohibits a subject to undergo an MRI.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ABT-981Also: lutikizumabABT-981 administered by subcutaneous injection	Biological	ABT-981
Placebo for ABT-981Placebo for ABT-981 administered by subcutaneous injection	Biological	Placebo

Primary outcome

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.

6 secondary outcomes

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
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
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
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
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
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

Results and safety

Results posted to the registry on 13 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	67	61
ABT-981	64	49

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

Time frame: Week 0 (Baseline), Week 16. Least squares mean (95% Confidence Interval). Unit: units on a scale

Measure	Placebo n = 65	ABT-981 n = 64
Value	-10.74 (-15.433 to -6.045)	-9.22 (-13.798 to -4.645)

Placebo vs ABT-981: LS Mean Difference: 1.52 (95% CI -1.944 to 4.990), p = 0.386, ANCOVA

Population analysed: mITT population: all randomized participants who received at least 1 dose of study drug.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2 of 67 (3%)	45 of 67 (67.2%)	Not reported
ABT-981	2 of 64 (3.1%)	49 of 64 (76.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30552176Kloppenburg 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.

Related trials for Erosive Hand Osteoarthritis

RecruitingPhase 2/3
Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments
Erosive Hand Osteoarthritis
Active, not recruitingPhase 4
Methotrexate in Erosive Inflammatory Hand Osteoarthritis
Hand Osteoarthritis, Erosive Osteoarthritis
Enrolling by invitationObservational study
A 30-month Follow-up of MERINO Participants to Evaluate Long-term Effects of Methotrexate in Erosive Hand OA.
Hand Osteoarthritis, Erosive Osteoarthritis
Active, not recruiting
DIGItal Cohort Osteoarthritis Design
Arthrosis of Hand

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AbbVie Inc study director

AbbVie

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-981 in people with Erosive Hand Osteoarthritis, run by AbbVie.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Week 16 (time frame: Week 0 (Baseline), Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02384538, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2017.