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)

NCT03192969 | Withdrawn Phase 3 DMC FDA Drug

• 2 other identifiers: IM101-6042016-002697-12
• Study Type: interventional
• Target: N/A
• Locations: 18 countries
• Sites: 88

Brief 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.

Conditions

Giant Cell Arteritis

Outcome Measures

Primary Outcomes (1)

• 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.

  40 weeks (week 12 to week 52)

Secondary Outcomes (14)

• Physician's Global Assessment of Disease Activity according to visual analog scale (VAS)

  Up to 52 weeks

• Subject Assessment of Disease Activity according to visual analog scale (VAS)

  Up to 52 weeks

• Short Form questionnaire-36 (SF-36)

  Up to 52 weeks

• Time from Week 12 to first relapse after achieving remission

  40 weeks (week 12 to week 52)

• Erythrocyte sedimentation rate (ESR)

  52 weeks

Study Arms (3)

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)

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)

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

Other: Placebo; Drug: Glucocorticoid Treatment

Interventions

Abatacept DRUG

Abatacept subcutaneous injection, 125 mg/prefilled syringe (125 mg/mL)

Abatacept Combination Therapy

Placebo OTHER

Placebo for abatacept for subcutaneous injection in 1 mL pre-filled syringes

Placebo Monotherapy- 28 Weeks; Placebo Monotherapy- 52 Weeks

Glucocorticoid Treatment DRUG

Glucocorticoid taper (up to 52-week or 28-week of oral prednisone/prednisolone)

Abatacept Combination Therapy; Placebo Monotherapy- 28 Weeks; Placebo Monotherapy- 52 Weeks

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (99)

Local Institution

Phoenix, Arizona, 85032, United States

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Fullerton, California, 92835, United States

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West Hollywood, California, 90048, United States

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Denver, Colorado, 80230, United States

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Iowa City, Iowa, 52242, United States

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Kansas City, Kansas, 66160, United States

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Rochester, Minnesota, 55905-0001, United States

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New York, New York, 10021, United States

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Cleveland, Ohio, 44195, United States

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Dayton, Ohio, 45417, United States

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Philadelphia, Pennsylvania, 19104, United States

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Charleston, South Carolina, 29406, United States

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Beaumont, Texas, 77702, United States

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Northmead, New South Wales, 2152, Australia

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Auchenflower, Queensland, 4066, Australia

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Woodville South, South Australia, 5001, Australia

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Malvern East, Victoria, 3145, Australia

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Nedlands, Western Australia, 6009, Australia

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Victoria Park, Western Australia, 6100, Australia

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Graz, 8036, Austria

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Stockerau, 2000, Austria

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Yvoir, 5530, Belgium

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Sofia, Sofia-Grad, 1606, Bulgaria

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Hamilton, Ontario, L8N 4A6, Canada

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Trois-Rivières, Quebec, G8Z 1Y2, Canada

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Saskatoon, Saskatchewan, S7K 0H6, Canada

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Aarhus C, 8000, Denmark

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Esbjerg, 6700, Denmark

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Glostrup Municipality, 2600, Denmark

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Holstebro, DK-7500, Denmark

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Odense C, 5000, Denmark

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Silkeborg, DK-8600, Denmark

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Tallinn, 11312, Estonia

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Tallinn, EE-13419, Estonia

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Tartu, 50107, Estonia

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Marseille, 13385, France

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Nantes, 44093, France

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Paris, 75018, France

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Paris, 75679, France

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Pau, 64000, France

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Toulouse, 31059, France

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Berlin, 13125, Germany

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Berlin, 14050, Germany

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Dresden, 01277, Germany

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Freiburg im Breisgau, 79095, Germany

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Hamburg, 22767, Germany

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Hanover, D30625, Germany

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Herne, 44652, Germany

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Kirchheim, 73230, Germany

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Rostock, 18059, Germany

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Tübingen, 72076, Germany

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W?rzburg, 97080, Germany

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Athens, 11527, Greece

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Larissa, 41110, Greece

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Thessaloniki, 56429, Greece

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Dublin, Ireland

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Catania, 95124, Italy

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Genova, 16132, Italy

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Milan, 20121, Italy

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Milan, 20132, Italy

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Milan, 20157, Italy

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Padua, 35128, Italy

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Pavia, 27100, Italy

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Prato, 51900, Italy

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Torino, 10126, Italy

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Almelo, 7609 PP, Netherlands

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Enschede, 7513 ER, Netherlands

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Groningen, 9713 GZ, Netherlands

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Helmond, 5707 HA, Netherlands

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Rotterdam, 3059XN, Netherlands

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Bydgoszcz, 85-168, Poland

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Krakow, 31-501, Poland

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Szczecin, 71-252, Poland

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Warsaw, 02-637, Poland

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Wroclaw, 52-416, Poland

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Cluj-Napoca, 400006, Romania

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Sibiu, 550245, Romania

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Belgrade, 11000, Serbia

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Barcelona, 08025, Spain

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Bilbao, 48013, Spain

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L'Hospitalet de Llobregat, 08907, Spain

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Madrid, 28007, Spain

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Madrid, 28034, Spain

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Madrid, 28040, Spain

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San Cristóbal de La Laguna, 38320, Spain

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Vitoria-Gasteiz, 01009, Spain

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Stockholm, SE-18288, Sweden

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Uppsala, 755 92, Sweden

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V?ster?s, 72189, Sweden

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Basel, 4031, Switzerland

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Bern, 3010, Switzerland

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Fribourg, 1708, Switzerland

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Sankt Gallen, 9007, Switzerland

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Z?rich, 8091, Switzerland

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Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom

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Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

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London, E1 1BB, United Kingdom

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Related Links

• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form

MeSH Terms

Conditions

Giant Cell Arteritis

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: June 20, 2017
• Study Start: July 15, 2017
• Primary Completion: June 7, 2020
• Study Completion: November 23, 2021
• Last Updated: July 12, 2017

Record last verified: 2017-07

Locations

IT (9); SE (3); FR (6); GR (3); RO (2); AU (6); BU (1); DK (6); ES (3); PL (5); IE (1); CA (3); DE (11); US (13); BE (3); GB (3); NL (5); CH (5)