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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)

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ClinicalTrials.gov Identifier: NCT03192969
Recruitment Status : Withdrawn (Business objectives have changed)
First Posted : June 20, 2017
Last Update Posted : July 12, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Giant Cell Arteritis Drug: Abatacept Other: Placebo Drug: Glucocorticoid Treatment Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 15, 2017
Estimated Primary Completion Date : June 7, 2020
Estimated Study Completion Date : November 23, 2021


Arm Intervention/treatment
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)
Other: Placebo
Placebo for abatacept for subcutaneous injection in 1 mL pre-filled syringes

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

Placebo Comparator: Placebo Monotherapy- 52 Weeks
Glucocorticoid therapy (52 week taper of oral prednisone daily) in combination with subcutaneous placebo weekly
Other: Placebo
Placebo for abatacept for subcutaneous injection in 1 mL pre-filled syringes

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Physician's Global Assessment of Disease Activity according to visual analog scale (VAS) [ Time Frame: Up to 52 weeks ]
    measured by assessment parameters

  2. Subject Assessment of Disease Activity according to visual analog scale (VAS) [ Time Frame: Up to 52 weeks ]
    measured by assessment parameters

  3. Short Form questionnaire-36 (SF-36) [ Time Frame: Up to 52 weeks ]
    Patient reported outcome assessment

  4. Time from Week 12 to first relapse after achieving remission [ Time Frame: 40 weeks (week 12 to week 52) ]
    measured by investigator

  5. Erythrocyte sedimentation rate (ESR) [ Time Frame: 52 weeks ]
    Mean change from baseline.

  6. C-reactive protein (CRP) [ Time Frame: 52 weeks ]
    Mean change from baseline.

  7. All adverse events and serious adverse events (AEs/SAEs) [ Time Frame: 52 weeks ]
    measured by incidence of AEs and SAEs

  8. Laboratory test abnormalities [ Time Frame: 52 weeks ]
    measured by laboratory test parameters

  9. 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

  10. 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.

  11. Cumulative glucocorticoid dose [ Time Frame: 52 weeks ]
    measured as the total glucocorticoid dose used during the treatment period

  12. EuroQOL 5 Dimensions (EQ-5D-3L) [ Time Frame: Up to 52 weeks ]
    Patient reported outcome assessment

  13. Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 8a [ Time Frame: Up to 52 weeks ]
    Patient reported outcome assessment

  14. Resource Utilization [ Time Frame: Up to 52 weeks ]
    Assessed by the number of hospitalizations



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192969


  Show 99 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03192969     History of Changes
Other Study ID Numbers: IM101-604
2016-002697-12 ( EudraCT Number )
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: July 12, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Arteritis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Prednisone
Abatacept
Glucocorticoids
Anti-Inflammatory Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents