Phase 3
Completed N=34
Benefits of Injectable Abatacept Using Magnetic Resonance Imaging (MRI) in Rheumatoid Arthritis (RA) Patients
Source: ClinicalTrials.gov NCT01351480 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: 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. — 27 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
27 | — |
| SECONDARY Patients With an Improvement in DAS Score Were Considered Responders at Week 48 |
25 | — |
| SECONDARY To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24 |
2; 2; 12; 11; 1; 2 | — |
| SECONDARY 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 |
20; 25 | — |
| SECONDARY Number of Patients With Adverse Events |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- Intramuscular(IM), Intravenous(IV) Intra-articular (IA) corticosteroids within 28 days prior to baseline
- Subjects who have a metal device affected by MRI (e.g. any type of electronic, mechanical or magnetic implant, metal slivers, metal objects, cardioverter defibrillator)
- Subjects who have received any disease modifying agent (DMARD) other than methotrexate within the past 28 days prior to baseline
Data sourced from ClinicalTrials.gov (NCT01351480). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.