Rheumatoid ArthritisPhase 3NCT01299961

Ultrasound Scores as Indication of Response to Subcutaneous Abatacept in Subjects With Rheumatoid Arthritis

A Phase 3 study testing abatacept in people with Rheumatoid Arthritis, run by University of California, Los Angeles at 1 site in United States.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: abatacept
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: Mar 2011to Feb 2015
Phase: Phase 3
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Over 18 years old
Has a diagnosis of rheumatoid arthritis
Stable DMARDs for at least 1 month (methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine)
Disease activity score DAS28/ESR > 3.2 or all must be met: TJC (tender joint count)>=4, SJC (swollen joint count)>=4
Must be able to understand information in the Informed Consent and comply with study requirements
Total ultrasound synovitis (inflammation of joint-lining membrane) power Doppler score >=1 for at least 2 joints and total synovitis score >=1 for at least 1 joint

Who cannot join

Current or prior use of biologic drugs (TNF inhibitors, IL-6 inhibitors, CD20 inhibitors, IL-1 inhibitors, etc.)
Pregnancy or breast feeding
Daily prednisone > 10mg (stable dose for at least 1 month)
Intra-articular steroid injection of the wrist or joints within last 2 months
History of a concomitant autoimmune disease such as lupus, psoriatic arthritis
History of cancer
Previous exposure to abatacept

Trial locations and contacts

1 site in 1 country.

United States1 site

UCLA David Geffen School of Medicine, Division of Rheumatology
Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Musculoskeletal Ultrasound as a Marker of Therapeutic Response to Abatacept in Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a chronic inflammatory disease (a long-lasting disease causing pain and swelling) associated with significant health problems. It is a difficult disease to manage as the disease is often unpredictable. RA causes inflammation (swelling) of the joints that can cause joint damage, deformity, and progressive disability and impairment. It is estimated that 1% of the world's population suffers from this disease.

The purpose of this research study is to determine if a change in inflammation seen on the ultrasound is a good indicator of how subjects' rheumatoid arthritis is responding to treatment of subcutaneous abatacept at 3 weeks, 3 months, 6 months, and 12 months.

Conditions: Rheumatoid Arthritis
Being tested: abatacept
Keywords: Rheumatoid Arthritis, Subcutaneous Abatacept, Ultrasound
Medical subject headings: Arthritis, Rheumatoid

What participants receive

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

abataceptDrug
125 mg once a week up to 12 months.

Study groups in NCT01299961
Study group	Role	What they receive
Subcutaneous Abatacept	Experimental	All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months. Receives: Drug: abatacept

What is being measured

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

12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score
The 7-joint US inflammatory score includes the addition of synovial hypertrophy scores and power doppler scores.
Measured: baseline, 12 months

Secondary outcomes (2)

12 Month Change in Power Doppler Ultrasound (PDUS) Scores
There were seven different joints in the hands and wrists evaluated to score the PDUS.
Measured: baseline, 12 months
12 Month Change in Gray-scale Ultrasound (GSUS)
There were seven different joints in the hands and wrists evaluated to score the GSUS.
Measured: baseline, 12 months

Timeline

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

Mar 2011Feb 2015

First posted21 Feb 2011 (estimated)
Study startMar 2011
Primary completionFeb 2013
Study completionFeb 2015

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 Rheumatoid ArthritisStudies of the same condition, open and under way.
More trials run by University of California, Los AngelesThe 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 3
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01299961
Sponsor's protocol ID: UCLA Rheumatology RA 001
Other IDs: IND 111281
Status last verified: May 2015
First submitted: 18 Feb 2011
Last updated: 10 Jun 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Charles-Schoeman C, Wang J, Shahbazian A, Wilhalme H, Brook J, Kaeley GS, Oganesian B, Ben-Artzi A, Elashoff DA, Ranganath VK. Power doppler ultrasound signal predicts abnormal HDL function in patients with rheumatoid arthritis. Rheumatol Int. 2023 Jun;43(6):1041-1053. doi: 10.1007/s00296-023-05285-7. Epub 2023 Feb 24.
PubMed 36828925

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?

See locations

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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Musculoskeletal Ultrasound as a Marker of Therapeutic Response to Abatacept in Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT01299961
Acronym / sponsor ID: UCLA Rheumatology RA 001
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis, Subcutaneous Abatacept, Ultrasound
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: University of California, Los AngelesUniversity, hospital or other
Study start: Mar 2011
Primary completion: Feb 2013 (actual)
Study completion: Feb 2015 (actual)
First posted: 21 Feb 2011 (estimated)
Results: Posted 30 Jan 2015

Clinical summary

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

Study design

Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Subcutaneous Abatacept	Experimental	Drug: abataceptAll subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Over 18 years old
Has a diagnosis of rheumatoid arthritis
Stable DMARDs for at least 1 month (methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine)
Disease activity score DAS28/ESR > 3.2 or all must be met: TJC (tender joint count)>=4, SJC (swollen joint count)>=4
Must be able to understand information in the Informed Consent and comply with study requirements

Key exclusion criteria (7 listed)

Current or prior use of biologic drugs (TNF inhibitors, IL-6 inhibitors, CD20 inhibitors, IL-1 inhibitors, etc.)
Pregnancy or breast feeding
Daily prednisone > 10mg (stable dose for at least 1 month)
Intra-articular steroid injection of the wrist or joints within last 2 months
History of a concomitant autoimmune disease such as lupus, psoriatic arthritis

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
abatacept125 mg once a week up to 12 months.	Drug	Subcutaneous Abatacept

Primary outcome

12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score
Time frame: baseline, 12 months
The 7-joint US inflammatory score includes the addition of synovial hypertrophy scores and power doppler scores.

2 secondary outcomes

12 Month Change in Power Doppler Ultrasound (PDUS) Scores
Time frame: baseline, 12 months
12 Month Change in Gray-scale Ultrasound (GSUS)
Time frame: baseline, 12 months

Results and safety

Results posted to the registry on 30 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subcutaneous Abatacept	25	19

Primary outcome: 12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score

Time frame: baseline, 12 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Subcutaneous Abatacept n = 19
Value	11.4 (13.1)

Subcutaneous Abatacept: Mean Difference (Final Values): 11.4, p <0.01, t-test, 2 sided

Population analysed: Total of 19 patients completed 12 mos

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subcutaneous Abatacept	0 of 25 (0%)	0 of 25 (0%)	Not reported

Limitations and caveats (from the sponsor): This is a very small open-label study of 25 patients on a FDA approved drug, where efficacy (by standard validated measures) and safety were not the primary end points.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36828925Charles-Schoeman C, Wang J, Shahbazian A, Wilhalme H, Brook J, Kaeley GS, Oganesian B, Ben-Artzi A, Elashoff DA, Ranganath VK. Power doppler ultrasound signal predicts abnormal HDL function in patients with rheumatoid arthritis. Rheumatol Int. 2023 Jun;43(6):1041-1053. doi: 10.1007/s00296-023-05285-7. Epub 2023 Feb 24.

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

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.

Veena K Ranganath, M.D. principal investigator

UCLA David Geffen School of Medicine, Division of Rheumatology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing abatacept in people with Rheumatoid Arthritis, run by University of California, Los Angeles at 1 site in United States.

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 6 inclusion and 7 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 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 30 Jan 2015). 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?

12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score (time frame: baseline, 12 months). 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 NCT01299961, 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 10 Jun 2015.