Giant Cell ArteritisPhase 3NCT03192969

A Study to Evaluate Efficacy and Safety of Subcutaneous Abatacept With Steroid Treatment Compared to Steroid Treatment Alone in Adults With Giant Cell Arteritis (GCA)

A Phase 3 study testing Abatacept and Glucocorticoid Treatment in people with Giant Cell Arteritis, run by Bristol-Myers Squibb at 99 sites in 21 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

To investigate the safety and efficacy of abatacept with steroid treatment in comparison to steroid treatment alone in up to a 28 week taper of steroid treatment to sustain remission of Giant Cell Arteritis in adults. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Giant Cell Arteritis
What is being tested?: Abatacept and Glucocorticoid Treatment
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: 99 sitesin 21 countries
Study dates: 15 Jul 2017to 23 Nov 2021
Phase: Phase 3
Are there results?: None posted in the registry

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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

New headache (new onset or new type of localized pain in the head)
Elevated ESR (≥ 50 mm/h by the Westergren method) or CRP ≥ 1 mg/dL
Temporal artery abnormality (i.e. temporal artery tenderness to palpation or decreased pulsation, unrelated to arteriosclerosis of cervical arteries)
Temporal artery biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells
Large vessel biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells or characteristic changes of large vessel stenosis or aneurysm secondary to GCA as seen by arteriography (Magnetic Resonance Imaging/ Magnetic Resonance Angiography), ultrasound (eg, halo sign on color duplex sonography), or CT scan
Patients must be treated with prednisone or prednisolone of 20-60 mg/day (prednisone equivalent) and be on a dose between 20-60 mg/day for at least 2 weeks prior to enrollment into the study

Who cannot join

Rheumatic disease other than GCA such as Takayasu's Arteritis, granulomatosis with polyangiitis (Wegener's), rheumatoid arthritis, systemic lupus erythematosus
Patients with unilateral blindness (partial or complete) or who have unstable or recurrent visual symptoms attributable to GCA within 4 weeks of randomization
Patients with a history of dissection of aorta
Patients with a history of myocardial infarction, stroke or transient ischemic attack attributable to GCA within the 3 months of screening
Patients who have been treated with intravenous ("pulse") doses of glucocorticoids defined as methylprednisolone > 1000 mg/day if given within 6 weeks of randomization
Patients who will require oral or IV glucocorticoid treatment during the trial for conditions other than GCA
Patients at risk of tuberculosis
Other protocol defined inclusion/exclusion criteria could apply

Trial locations and contacts

99 sites in 21 countries.

Country

City, postcode or hospital

99 sites in 21 countries

United States13 sites

Local Institution
Beaumont, Texas, 77702
Local Institution
Charleston, South Carolina, 29406
Local Institution
Cleveland, Ohio, 44195
Local Institution
Dayton, Ohio, 45417
Local Institution
Denver, Colorado, 80230
Local Institution
Fullerton, California, 92835
Local Institution
Iowa City, Iowa, 52242
Local Institution
Kansas City, Kansas, 66160
Local Institution
New York, New York, 10021
Local Institution
Philadelphia, Pennsylvania, 19104
Local Institution
Phoenix, Arizona, 85032
Local Institution
Rochester, Minnesota, 55905-0001
Local Institution
West Hollywood, California, 90048

Other trials in United States

Germany11 sites

Local Institution
Berlin, 13125
Local Institution
Berlin, 14050
Local Institution
Dresden, 01277
Local Institution
Freiburg im Breisgau, 79095
Local Institution
Hamburg, 22767
Local Institution
Hanover, D30625
Local Institution
Herne, 44652
Local Institution
Kirchheim, 73230
Local Institution
Rostock, 18059
Local Institution
Tübingen, 72076
Local Institution
W?rzburg, 97080

Other trials in Germany

Italy9 sites

Local Institution
Catania, 95124
Local Institution
Genova, 16132
Local Institution
Milan, 20121
Local Institution
Milan, 20132
Local Institution
Milan, 20157
Local Institution
Padova, 35128
Local Institution
Pavia, 27100
Local Institution
Prato, 51900
Local Institution
Torino, 10126

Other trials in Italy

Spain8 sites

Local Institution
Barcelona, 08025
Local Institution
Bilbao, 48013
Local Institution
L'Hospitalet de Llobregat, 08907
Local Institution
Madrid, 28007
Local Institution
Madrid, 28034
Local Institution
Madrid, 28040
Local Institution
San Cristóbal de La Laguna, 38320
Local Institution
Vitoria-Gasteiz, 01009

Other trials in Spain

Australia6 sites

Local Institution
Auchenflower, Queensland, 4066
Local Institution
Malvern East, Victoria, 3145
Local Institution
Nedlands, Western Australia, 6009
Local Institution
Northmead, New South Wales, 2152
Local Institution
Victoria Park, Western Australia, 6100
Local Institution
Woodville South, South Australia, 5001

Other trials in Australia

Denmark6 sites

Local Institution
Aarhus C, 8000
Local Institution
Esbjerg, 6700
Local Institution
Glostrup Municipality, 2600
Local Institution
Holstebro, DK-7500
Local Institution
Odense C, 5000
Local Institution
Silkeborg, DK-8600

Other trials in Denmark

France6 sites

Local Institution
Marseille, 13385
Local Institution
Nantes, 44093
Local Institution
Paris, 75018
Local Institution
Paris, 75679
Local Institution
Pau, 64000
Local Institution
Toulouse, 31059

Other trials in France

Netherlands5 sites

Local Institution
Almelo, 7609 PP
Local Institution
Enschede, 7513 ER
Local Institution
Groningen, 9713 GZ
Local Institution
Helmond, 5707 HA
Local Institution
Rotterdam, 3059XN

Other trials in Netherlands

Poland5 sites

Local Institution
Bydgoszcz, 85-168
Local Institution
Krakow, 31-501
Local Institution
Szczecin, 71-252
Local Institution
Warsaw, 02-637
Local Institution
Wroclaw, 52-416

Other trials in Poland

Switzerland5 sites

Local Institution
Basel, 4031
Local Institution
Bern, 3010
Local Institution
Fribourg, 1708
Local Institution
Sankt Gallen, 9007
Local Institution
Z?rich, 8091

Other trials in Switzerland

Belgium3 sites

Local Institution
Leuven, 3000
Local Institution
Liège, 4000
Local Institution
Yvoir, 5530

Other trials in Belgium

Canada3 sites

Local Institution
Hamilton, Ontario, L8N 4A6
Local Institution
Saskatoon, Saskatchewan, S7K 0H6
Local Institution
Trois-Rivières, Quebec, G8Z 1Y2

Other trials in Canada

Estonia3 sites

Local Institution
Tallinn, 11312
Local Institution
Tallinn, EE-13419
Local Institution
Tartu, 50107

Other trials in Estonia

Greece3 sites

Local Institution
Athens, 11527
Local Institution
Larissa, 41110
Local Institution
Thessaloniki, 56429

Other trials in Greece

Sweden3 sites

Local Institution
Stockholm, SE-18288
Local Institution
Uppsala, 755 92
Local Institution
V?ster?s, 72189

Other trials in Sweden

United Kingdom3 sites

Local Institution
London, E1 1BB
Local Institution
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
Local Institution
Westcliff-on-Sea, Essex, SS0 0RY

Other trials in United Kingdom

Austria2 sites

Local Institution
Graz, 8036
Local Institution
Stockerau, 2000

Other trials in Austria

Romania2 sites

Local Institution
Cluj-Napoca, 400006
Local Institution
Sibiu, 550245

Other trials in Romania

Bulgaria1 site

Local Institution
Sofia, Sofia-Grad, 1606

Other trials in Bulgaria

Ireland1 site

Local Institution
Dublin

Other trials in Ireland

Serbia1 site

Local Institution
Belgrade, 11000

Other trials in Serbia

About this study

Official title: A Phase III Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Combination With Glucocorticoid Treatment Compared to Glucocorticoid Monotherapy in Adults With Giant Cell Arteritis

Conditions: Giant Cell Arteritis
Being tested: Abatacept, Placebo, Glucocorticoid Treatment
Medical subject headings: Giant Cell Arteritis

What participants receive

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

AbataceptDrug
Abatacept subcutaneous injection, 125 mg/prefilled syringe (125 mg/mL)
PlaceboOther
Placebo for abatacept for subcutaneous injection in 1 mL pre-filled syringes
Glucocorticoid TreatmentDrug
Glucocorticoid taper (up to 52-week or 28-week of oral prednisone/prednisolone)

Study groups in NCT03192969
Study group	Role	What they receive
Abatacept Combination Therapy	Experimental	Abatacept subcutaneous injection (125 mg/mL prefilled syringe weekly) in combination with glucocorticoid therapy (up to 28-week taper of oral prednisone daily) Receives: Drug: Abatacept; Drug: Glucocorticoid Treatment
Placebo Monotherapy- 28 Weeks	Placebo comparator	Glucocorticoid therapy (28-week taper of oral prednisone daily) in combination with placebo subcutaneous injection (1 mL pre-filled syringe weekly) Receives: Other: Placebo; Drug: Glucocorticoid Treatment
Placebo Monotherapy- 52 Weeks	Placebo comparator	Glucocorticoid therapy (52 week taper of oral prednisone daily) in combination with subcutaneous placebo weekly Receives: Other: Placebo; Drug: Glucocorticoid Treatment

What is being measured

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

Patients in sustained remission
Assessment based on 2-sided stratified Cochran-Mantel-Haenszel (CMH) chi-square test, stratified by baseline glucocorticoid dose group (20-< 30, 30-< 40, 40-< 50 and 50-60 mg/day) and GCA diagnosis (New vs Relapse) at a 5% significance level. Remission is defined as the absence of clinical signs and symptoms of active disease attributable to GCA.
Measured: 40 weeks (week 12 to week 52)

Secondary outcomes (14)

Physician's Global Assessment of Disease Activity according to visual analog scale (VAS)
measured by assessment parameters
Measured: Up to 52 weeks
Subject Assessment of Disease Activity according to visual analog scale (VAS)
measured by assessment parameters
Measured: Up to 52 weeks
Short Form questionnaire-36 (SF-36)
Patient reported outcome assessment
Measured: Up to 52 weeks
Time from Week 12 to first relapse after achieving remission
measured by investigator
Measured: 40 weeks (week 12 to week 52)
Erythrocyte sedimentation rate (ESR)
Mean change from baseline.
Measured: 52 weeks
C-reactive protein (CRP)
Mean change from baseline.
Measured: 52 weeks
All adverse events and serious adverse events (AEs/SAEs)
measured by incidence of AEs and SAEs
Measured: 52 weeks
Laboratory test abnormalities
measured by laboratory test parameters
Measured: 52 weeks
Cmin (μg/mL): Trough level serum concentration of abatacept prior to the administration of the subcutaneous injection
measured by serum concentration
Measured: 104 weeks
Positive abatacept response relative to baseline
A validated, sensitive, electrochemiluminescence assay (ECL) method will be used to analyze the presence of anti-abatacept antibodies in serum. Samples that are confirmed positive for antibodies specific to the CTLA4 region of abatacept will be further analyzed with a validated, in vitro, cell-based bioassay to determine whether the sera contained abatacept neutralizing activity.
Measured: 52 weeks
Cumulative glucocorticoid dose
measured as the total glucocorticoid dose used during the treatment period
Measured: 52 weeks
EuroQOL 5 Dimensions (EQ-5D-3L)
Patient reported outcome assessment
Measured: Up to 52 weeks
Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 8a
Patient reported outcome assessment
Measured: Up to 52 weeks
Resource Utilization
Assessed by the number of hospitalizations
Measured: Up to 52 weeks

Timeline

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

15 Jul 201723 Nov 2021

First posted20 Jun 2017
Study start15 Jul 2017 (estimated)
Primary completion7 Jun 2020 (estimated)
Study completion23 Nov 2021 (estimated)

Why it stopped: Business objectives have changed

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03192969
Sponsor's protocol ID: IM101-604
Other IDs: 2016-002697-12, 2016
Status last verified: Jul 2017
First submitted: 14 Jun 2017
Last updated: 12 Jul 2017
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

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

Not yet recruitingPhase 3
Aspirin for the Prevention of Ischemic Complications in Giant Cell Arteritis
Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS)
RecruitingObservational study
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Takayasu's Arteritis, Giant Cell Arteritis
Active, not recruitingObservational study
The Applanation Tonometry in GCA Pilot
Giant Cell Arteritis
RecruitingObservational study
Optic Nerve Sheath Ultrasound in Giant Cell Arteritis
Giant Cell Arteritis, Anterior Ischemic Optic Neuropathy
RecruitingObservational study
Early Temporal Dynamics of Optic Nerve Sheath Diameter After Therapy in GCA
Giant Cell Arteritis, Temporal Arteritis

All Giant Cell Arteritis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Combination With Glucocorticoid Treatment Compared to Glucocorticoid Monotherapy in Adults With Giant Cell Arteritis
ClinicalTrials.gov ID: NCT03192969
Acronym / sponsor ID: IM101-604
Conditions: Giant Cell Arteritis
Phase: Phase 3
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Business objectives have changed
Enrolment: 0 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 15 Jul 2017 (estimated)
Primary completion: 7 Jun 2020 (estimated)
Study completion: 23 Nov 2021 (estimated)
First posted: 20 Jun 2017 (actual)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Abatacept Combination Therapy	Experimental	Drug: Abatacept, Drug: Glucocorticoid TreatmentAbatacept subcutaneous injection (125 mg/mL prefilled syringe weekly) in combination with glucocorticoid therapy (up to 28-week taper of oral prednisone daily)
Placebo Monotherapy- 28 Weeks	Placebo comparator	Other: Placebo, Drug: Glucocorticoid TreatmentGlucocorticoid therapy (28-week taper of oral prednisone daily) in combination with placebo subcutaneous injection (1 mL pre-filled syringe weekly)
Placebo Monotherapy- 52 Weeks	Placebo comparator	Other: Placebo, Drug: Glucocorticoid TreatmentGlucocorticoid therapy (52 week taper of oral prednisone daily) in combination with subcutaneous placebo weekly

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

New headache (new onset or new type of localized pain in the head)
Elevated ESR (≥ 50 mm/h by the Westergren method) or CRP ≥ 1 mg/dL
Temporal artery abnormality (i.e. temporal artery tenderness to palpation or decreased pulsation, unrelated to arteriosclerosis of cervical arteries)
Temporal artery biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells
Large vessel biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells or characteristic changes of large vessel stenosis or aneurysm secondary to GCA as seen by arteriography (Magnetic Resonance Imaging/ Magnetic Resonance Angiography), ultrasound (eg, halo sign on color duplex sonography), or CT scan

Key exclusion criteria (8 listed)

Rheumatic disease other than GCA such as Takayasu's Arteritis, granulomatosis with polyangiitis (Wegener's), rheumatoid arthritis, systemic lupus erythematosus
Patients with unilateral blindness (partial or complete) or who have unstable or recurrent visual symptoms attributable to GCA within 4 weeks of randomization
Patients with a history of dissection of aorta
Patients with a history of myocardial infarction, stroke or transient ischemic attack attributable to GCA within the 3 months of screening
Patients who have been treated with intravenous ("pulse") doses of glucocorticoids defined as methylprednisolone > 1000 mg/day if given within 6 weeks of randomization

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
AbataceptAbatacept subcutaneous injection, 125 mg/prefilled syringe (125 mg/mL)	Drug	Abatacept Combination Therapy
PlaceboPlacebo for abatacept for subcutaneous injection in 1 mL pre-filled syringes	Other	Placebo Monotherapy- 28 Weeks, Placebo Monotherapy- 52 Weeks
Glucocorticoid TreatmentGlucocorticoid taper (up to 52-week or 28-week of oral prednisone/prednisolone)	Drug	Abatacept Combination Therapy, Placebo Monotherapy- 28 Weeks, Placebo Monotherapy- 52 Weeks

Primary outcome

Patients in sustained remission
Time frame: 40 weeks (week 12 to week 52)
Assessment based on 2-sided stratified Cochran-Mantel-Haenszel (CMH) chi-square test, stratified by baseline glucocorticoid dose group (20-< 30, 30-< 40, 40-< 50 and 50-60 mg/day) and GCA diagnosis (New vs Relapse) at a 5% significance level. Remission is defined as the absence of clinical signs and symptoms of active disease attributable to GCA.

14 secondary outcomes

Physician's Global Assessment of Disease Activity according to visual analog scale (VAS)
Time frame: Up to 52 weeks
Subject Assessment of Disease Activity according to visual analog scale (VAS)
Time frame: Up to 52 weeks
Short Form questionnaire-36 (SF-36)
Time frame: Up to 52 weeks
Time from Week 12 to first relapse after achieving remission
Time frame: 40 weeks (week 12 to week 52)
Erythrocyte sedimentation rate (ESR)
Time frame: 52 weeks
C-reactive protein (CRP)
Time frame: 52 weeks
All adverse events and serious adverse events (AEs/SAEs)
Time frame: 52 weeks
Laboratory test abnormalities
Time frame: 52 weeks
Cmin (μg/mL): Trough level serum concentration of abatacept prior to the administration of the subcutaneous injection
Time frame: 104 weeks
Positive abatacept response relative to baseline
Time frame: 52 weeks
Cumulative glucocorticoid dose
Time frame: 52 weeks
EuroQOL 5 Dimensions (EQ-5D-3L)
Time frame: Up to 52 weeks
Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 8a
Time frame: Up to 52 weeks
Resource Utilization
Time frame: Up to 52 weeks

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.

Related trials for Giant Cell Arteritis

Not yet recruitingPhase 3
Aspirin for the Prevention of Ischemic Complications in Giant Cell Arteritis
Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS)
RecruitingObservational study
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Takayasu's Arteritis, Giant Cell Arteritis
Active, not recruitingObservational study
The Applanation Tonometry in GCA Pilot
Giant Cell Arteritis
RecruitingObservational study
Optic Nerve Sheath Ultrasound in Giant Cell Arteritis
Giant Cell Arteritis, Anterior Ischemic Optic Neuropathy
RecruitingObservational study
Early Temporal Dynamics of Optic Nerve Sheath Diameter After Therapy in GCA
Giant Cell Arteritis, Temporal Arteritis

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.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

99 sites in 21 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abatacept and Glucocorticoid Treatment in people with Giant Cell Arteritis, run by Bristol-Myers Squibb at 99 sites in 21 countries.

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 8 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: withdrawn, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, Germany, Italy, Spain, Australia and 16 more countries. 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. 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 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Patients in sustained remission (time frame: 40 weeks (week 12 to week 52)). 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 NCT03192969.

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 12 Jul 2017; AzTrials last refreshed its copy on 6 Nov 2026.