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)

July 10, 2017 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Northmead, New South Wales, Australia, 2152
        • Local Institution
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Local Institution
    • South Australia
      • Woodville South, South Australia, Australia, 5001
        • Local Institution
    • Victoria
      • Malvern East, Victoria, Australia, 3145
        • Local Institution
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Local Institution
      • Victoria Park, Western Australia, Australia, 6100
        • Local Institution
  • Austria
      • Graz, Austria, 8036
        • Local Institution
      • Stockerau, Austria, 2000
        • Local Institution
  • Belgium
      • Leuven, Belgium, 3000
        • Local Institution
      • Li?ge, Belgium, 4000
        • Local Institution
      • Yvoir, Belgium, 5530
        • Local Institution
  • Bulgaria
    • Sofia-grad
      • Sofia, Sofia-grad, Bulgaria, 1606
        • Local Institution
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Local Institution
    • Quebec
      • Trois-Rivieres, Quebec, Canada, G8Z 1Y2
        • Local Institution
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
        • Local Institution
  • Denmark
      • Aarhus C, Denmark, 8000
        • Local Institution
      • Esbjerg, Denmark, 6700
        • Local Institution
      • Glostrup, Denmark, 2600
        • Local Institution
      • Holstebro, Denmark, DK-7500
        • Local Institution
      • Odense C, Denmark, 5000
        • Local Institution
      • Silkeborg, Denmark, DK-8600
        • Local Institution
  • Estonia
      • Tallinn, Estonia, 11312
        • Local Institution
      • Tallinn, Estonia, EE-13419
        • Local Institution
      • Tartu, Estonia, 50107
        • Local Institution
  • France
      • Marseille, France, 13385
        • Local Institution
      • Nantes, France, 44093
        • Local Institution
      • Paris, France, 75018
        • Local Institution
      • Paris Cedex 14, France, 75679
        • Local Institution
      • Pau, France, 64000
        • Local Institution
      • Toulouse, France, 31059
        • Local Institution
  • Germany
      • Berlin, Germany, 14050
        • Local Institution
      • Berlin, Germany, 13125
        • Local Institution
      • Dresden, Germany, 01277
        • Local Institution
      • Freiburg im Breisgau, Germany, 79095
        • Local Institution
      • Hamburg, Germany, 22767
        • Local Institution
      • Hannover, Germany, D30625
        • Local Institution
      • Herne, Germany, 44652
        • Local Institution
      • Kirchheim, Germany, 73230
        • Local Institution
      • Rostock, Germany, 18059
        • Local Institution
      • Tubingen, Germany, 72076
        • Local Institution
      • W?rzburg, Germany, 97080
        • Local Institution
  • Greece
      • Athens, Greece, 11527
        • Local Institution
      • Larissa, Greece, 41110
        • Local Institution
      • Thessaloniki, Greece, 56429
        • Local Institution
  • Ireland
      • Dublin, Ireland
        • Local Institution
  • Italy
      • Catania, Italy, 95124
        • Local Institution
      • Genova, Italy, 16132
        • Local Institution
      • Milano, Italy, 20132
        • Local Institution
      • Milano, Italy, 20121
        • Local Institution
      • Milano, Italy, 20157
        • Local Institution
      • Padova, Italy, 35128
        • Local Institution
      • Pavia, Italy, 27100
        • Local Institution
      • Prato, Italy, 51900
        • Local Institution
      • Torino, Italy, 10126
        • Local Institution
  • Netherlands
      • Almelo, Netherlands, 7609 PP
        • Local Institution
      • Enschede, Netherlands, 7513 ER
        • Local Institution
      • Groningen, Netherlands, 9713 GZ
        • Local Institution
      • Helmond, Netherlands, 5707 HA
        • Local Institution
      • Rotterdam, Netherlands, 3059XN
        • Local Institution
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Local Institution
      • Krakow, Poland, 31-501
        • Local Institution
      • Szczecin, Poland, 71-252
        • Local Institution
      • Warszawa, Poland, 02-637
        • Local Institution
      • Wroclaw, Poland, 52-416
        • Local Institution
  • Romania
      • Cluj-Napoca, Romania, 400006
        • Local Institution
      • Sibiu, Romania, 550245
        • Local Institution
  • Serbia
      • Belgrade, Serbia, 11000
        • Local Institution
  • Spain
      • Barcelona, Spain, 08025
        • Local Institution
      • Bilbao, Spain, 48013
        • Local Institution
      • L'Hospitalet de Llobregat, Spain, 08907
        • Local Institution
      • La Laguna, Spain, 38320
        • Local Institution
      • Madrid, Spain, 28034
        • Local Institution
      • Madrid, Spain, 28007
        • Local Institution
      • Madrid, Spain, 28040
        • Local Institution
      • Vitoria, Spain, 01009
        • Local Institution
  • Sweden
      • Stockholm, Sweden, SE-18288
        • Local Institution
      • Uppsala, Sweden, 755 92
        • Local Institution
      • V?ster?s, Sweden, 72189
        • Local Institution
  • Switzerland
      • Basel, Switzerland, 4031
        • Local Institution
      • Bern, Switzerland, 3010
        • Local Institution
      • Freiburg, Switzerland, 1708
        • Local Institution
      • St. Gallen, Switzerland, 9007
        • Local Institution
      • Z?rich, Switzerland, 8091
        • Local Institution
  • United Kingdom
      • London, United Kingdom, E1 1BB
        • Local Institution
    • Essex
      • Westcliff-on-Sea, Essex, United Kingdom, SS0 0RY
        • Local Institution
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
        • Local Institution
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Local Institution
    • California
      • Fullerton, California, United States, 92835
        • Local Institution
      • West Hollywood, California, United States, 90048
        • Local Institution
    • Colorado
      • Denver, Colorado, United States, 80230
        • Local Institution
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Local Institution
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Local Institution
    • Minnesota
      • Rochester, Minnesota, United States, 55905-0001
        • Local Institution
    • New York
      • New York, New York, United States, 10021
        • Local Institution
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Local Institution
      • Dayton, Ohio, United States, 45417
        • Local Institution
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Local Institution
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Local Institution
    • Texas
      • Beaumont, Texas, United States, 77702
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Abatacept Combination Therapy
Abatacept subcutaneous injection (125 mg/mL prefilled syringe weekly) in combination with glucocorticoid therapy (up to 28-week taper of oral prednisone daily)
Drug: Abatacept
Abatacept subcutaneous injection, 125 mg/prefilled syringe (125 mg/mL)
Drug: Glucocorticoid Treatment
Glucocorticoid taper (up to 52-week or 28-week of oral prednisone/prednisolone)
Placebo Comparator: Placebo Monotherapy- 28 Weeks
Glucocorticoid therapy (28-week taper of oral prednisone daily) in combination with placebo subcutaneous injection (1 mL pre-filled syringe weekly)
Drug: Glucocorticoid Treatment
Glucocorticoid taper (up to 52-week or 28-week of oral prednisone/prednisolone)
Other: Placebo
Placebo for abatacept for subcutaneous injection in 1 mL pre-filled syringes
Placebo Comparator: Placebo Monotherapy- 52 Weeks
Glucocorticoid therapy (52 week taper of oral prednisone daily) in combination with subcutaneous placebo weekly
Drug: Glucocorticoid Treatment
Glucocorticoid taper (up to 52-week or 28-week of oral prednisone/prednisolone)
Other: Placebo
Placebo for abatacept for subcutaneous injection in 1 mL pre-filled syringes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
40 weeks (week 12 to week 52)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physician's Global Assessment of Disease Activity according to visual analog scale (VAS)
Time Frame: Up to 52 weeks
measured by assessment parameters
Up to 52 weeks
Subject Assessment of Disease Activity according to visual analog scale (VAS)
Time Frame: Up to 52 weeks
measured by assessment parameters
Up to 52 weeks
Short Form questionnaire-36 (SF-36)
Time Frame: Up to 52 weeks
Patient reported outcome assessment
Up to 52 weeks
Time from Week 12 to first relapse after achieving remission
Time Frame: 40 weeks (week 12 to week 52)
measured by investigator
40 weeks (week 12 to week 52)
Erythrocyte sedimentation rate (ESR)
Time Frame: 52 weeks
Mean change from baseline.
52 weeks
C-reactive protein (CRP)
Time Frame: 52 weeks
Mean change from baseline.
52 weeks
All adverse events and serious adverse events (AEs/SAEs)
Time Frame: 52 weeks
measured by incidence of AEs and SAEs
52 weeks
Laboratory test abnormalities
Time Frame: 52 weeks
measured by laboratory test parameters
52 weeks
Cmin (μg/mL): Trough level serum concentration of abatacept prior to the administration of the subcutaneous injection
Time Frame: 104 weeks
measured by serum concentration
104 weeks
Positive abatacept response relative to baseline
Time Frame: 52 weeks
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.
52 weeks
Cumulative glucocorticoid dose
Time Frame: 52 weeks
measured as the total glucocorticoid dose used during the treatment period
52 weeks
EuroQOL 5 Dimensions (EQ-5D-3L)
Time Frame: Up to 52 weeks
Patient reported outcome assessment
Up to 52 weeks
Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 8a
Time Frame: Up to 52 weeks
Patient reported outcome assessment
Up to 52 weeks
Resource Utilization
Time Frame: Up to 52 weeks
Assessed by the number of hospitalizations
Up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 7, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 23, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IM101-604
  • 2016-002697-12 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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