Benefits of Injectable Abatacept Using Magnetic Resonance Imaging (MRI) in Rheumatoid Arthritis (RA) Patients

NCT01351480 | Completed Phase 3 Results DMC

• 1 other identifier: IM101-306
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the use of sub-cutaneous (SC) abatacept provides any structural benefit in patients with rheumatoid arthritis who have failed prior use of TNF therapy.

Conditions

Rheumatoid Arthritis

Keywords

Auto-immune Disease; Arthritis; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With an Improvement in Bone Edema/Osteitis on Low-field MRI in Rheumatoid Arthritis Patients on Weekly SC Abatacept in Combination With Methotrexate Over a 12-month Period.

  bone edema/osteitis using low-field MRI analysis of 25 anatomical locations in the wrist and hand and scoring the volume of the original articular bone in 0.5 increments from 0-3, with each increment in the scale representing 33% of the volume of the peripheral 1 cm of original (eroded + residual) articular bone.

  MRIs at Baseline and Week 48

Secondary Outcomes (4)

• Patients With an Improvement in DAS Score Were Considered Responders at Week 48

  The DAS 28 score will be performed at baseline and 48

• To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24

  Patient DAS 28 scores will be measured at baseline and weeks 12, 24, 48 and disease activity will be recorded at Week 48

• the Clinical Outcomes Measurements (American College of Rheumatology Activity Scoring, Health Assessment The Number of Patients With a Clinical Response at Week 24 and 48

  week 24 and Week 48

• Number of Patients With Adverse Events

  all adverse events will be captured from Day 1 up to 52 weeks

Study Arms (1)

abatacept

OTHER

open label use of abatacept for 12 months

Biological: abatacept

Interventions

abatacept BIOLOGICAL

Abatacept administered SC weekly at 125 mg dose

Also known as: orencia

abatacept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to give written informed consent
• Patients must have a diagnosis of rheumatoid arthritis \> 3 months
• Patients must have been receiving methotrexate for 12 weeks prior to screening at a dose of 10mg - 25 mg weekly.
• Patient must have had an inadequate response after receiving or previously receiving one (1) but no more than two (2) anti-TNF biologic agents
• Age \>/= 18 yrs
• Must have active RA as defined by a DAS28 (Erythrocyte sedimentation rate) score \>4.4
• Must have synovitis of at least two joints in one hand/wrist at screening and baseline
• Must have a negative Pregnancy test and use adequate method of contraception throughout the trial
• Stable use of Corticosteroids is permitted
• Stable use of Non-steroidal anti-inflammatory drugs is permitted

You may not qualify if:

• Functional Class IV
• Pregnancy or breastfeeding
• History of any other inflammatory arthritis
• Sexually active patients who are not using acceptable birth control
• Subjects who have undergone metacarpophalangeal (MCP) arthroplasty or anticipate the need for such a procedure
• Subjects with a history of cancer in the last five years other than non melanoma skin cancers
• Subjects who are unable to comply with study and followup procedures
• Subjects who have current or severe symptoms of renal, hepatic, hematologic, gastrointestinal, pulmonary cardiac, neurologic, or cerebral disease
• Subjects who currently abuse drugs or alcohol
• Subjects with evidence of active or latent bacterial or viral infections at the time of enrollment
• Subjects who have received live vaccines within 4 months of first dose of study medication
• Subjects with herpes zoster or cytomegalovirus that resolved less than two months prior to dosing
• Subjects at risk for tuberculosis (TB). Specifically excluded will be subjects with a history of active TB within the last 3 years and subjects with latent TB must have a negative chest X-ray and be started on treatment for at least 28 days prior to dosing.
• Prior treatment with Rituximab within 12 months
• Prior treatment with more than 2 TNFs

Sponsors & Collaborators

• Arthritis & Rheumatic Disease Specialties Research: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Arthritis & Rheumatic Disease Specialties Research

Aventura, Florida, 33180, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue 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

Results Point of Contact

• Title: Norman B Gaylis, MD
• Organization: AARDS Research, Inc.

drnbg@rheum-care.com

305-652-6676

Study Officials

• Norman B Gaylis, MD

  Arthritis & Rheumatic Disease Specialties Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 6, 2011
• First Posted: May 11, 2011
• Study Start: June 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 13, 2017
• Results First Posted: March 13, 2017

Record last verified: 2017-01

Locations

US (1)