A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects

Completed · Phase 4 · Has a placebo group

Conditions studied: Rheumatoid Arthritis, Musculoskeletal and Connective Tissue Diseases

In brief

The primary objective of the study was to investigate the association between residual disease activity at Baseline as detected by Magnetic Resonance Imaging (MRI) and the occurrence of flares in participants with rheumatoid arthritis (RA) randomized to an adalimumab dose tapering regimen controlled by adalimumab withdrawal.

Key facts

Study ID

NCT02198651

Run by

AbbVie

People needed

149

Starts

2015-01-05

Expected to finish

2018-08-08

Last updated by the study team

2019-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant had a diagnosis of rheumatoid arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) classification criteria and/or the ACR /European League Against Rheumatism (EULAR) 2010 classification criteria (any duration since diagnosis).
• Participant must have met the following criteria:
• Must have been treated with adalimumab 40 mg subcutaneously every other week (sc eow) for at least 12 months prior to Week 0 Visit
• Must have been treated with concomitant methotrexate (MTX) at a stable dose (oral, sc or intramuscular (im) at any dose) for at least 12 weeks prior to Week 0 Visit or if not on MTX, must have been treated with other allowed conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) at a stable dose for at least 12 weeks prior to Week 0 Visit or if not treated with csDMARDs must maintain this regimen for at least 12 weeks prior to Week 0 Visit.
• Participant must be in sustained clinical remission based on the following:
• At least one documented 4 or 3 (if Patient's Global Assessment ; PGA is not available) variables Disease Activity Score 28 Erythrocyte sedimentation rate (DAS28 ESR) or DAS28 C-reactive protein (CRP) < 2.6 (or calculated based on documented components of the DAS28) in the participant's chart 6 months or longer prior to the Screening Visit;
• 4 variables DAS28 (ESR) assessed at Screening < 2.6, with all components including ESR assessed at Screening.
• If participant was receiving concomitant allowed csDMARDs (in addition or not to MTX) the dose must have been stable for at least 12 weeks prior to the Week 0 Visit (e.g., chloroquine, hydroxychloroquine, sulfasalazine, gold formulations [including auranofin, gold sodium thiomalate, and aurothioglucose] and/or leflunomide).
• If participant was receiving concomitant oral corticosteroids, prednisone or equivalent must have been < 10 mg/day and the dose must have been stable for at least 4 weeks prior to the Week 0 Visit.
• If participant was receiving concomitant non-steroidal anti-inflammatory drugs (NSAIDs), tramadol or other equivalent opioids and/or non-opioid analgesics, the dose and/or therapeutic scheme must have been stable for at least 4 weeks prior to the Week 0 Visit.
• Participant must have been able and willing to provide written informed consent and comply with the requirements of this study protocol.

You may not qualify if…

• Any 4 or 3 (if PGA is not available) variables DAS28 (ESR) or DAS28 (CRP) (or calculated based on documented components of the DAS28) assessed within 6 months prior to the Screening Visit ≥ 2.6.
• Participant was on an additional concomitant biological disease-modifying anti-rheumatic drug (bDMARD) (including but not limited to abatacept, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab or tocilizumab).
• Participant had been treated with intra-articular or parenteral corticosteroids within the last four weeks before Screening.
• Participant had undergone joint surgery within 12 weeks of Screening (at joints to be assessed by magnetic resonance imaging (MRI) and/or ultrasound).
• Participant had a medical condition precluding an MRI (e.g. magnetic activated implanted devices - cardiac pace-maker, insulin pump, neuro stimulators, etc. and metallic devices or fragments or clips in the eye, brain or spinal canal and in the hand/wrist undergoing MRI)
• Participant had a medical condition precluding a contrast MRI with gadolinium [e.g. nephrogenic systemic fibrosis, previous anaphylactic/anaphylactoid reaction to gadolinium containing contrast agent, pregnancy or breast feeding, severe renal insufficiency with an estimated Glomerular Filtration Rate (eGFR) below 30 mL/min/1.73m\^2 at Screening, hepato-renal syndrome, severe chronic liver function impairment]
• Participant had been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half-lives (whichever is longer) of the drug prior to the Screening Visit.

Where it is running

• Westlake Medical Research (WMR) Clinical Trials /ID# 155386 — Thousand Oaks, California, United States
• University of Florida /ID# 144851 — Jacksonville, Florida, United States
• North Georgia Rheumatology Grp /ID# 155225 — Lawrenceville, Georgia, United States
• The Arthritis & Diabetes Clinic, Inc. /ID# 149017 — Monroe, Louisiana, United States
• Aa Mrc Llc /Id# 151933 — Grand Blanc, Michigan, United States
• North Mississippi Med Clinics /ID# 149443 — Tupelo, Mississippi, United States
• Montefiore Medical Center /ID# 155013 — The Bronx, New York, United States
• Shanahan Rheuma & Immuno /ID# 148689 — Raleigh, North Carolina, United States
• Altoona Ctr Clinical Res /ID# 148448 — Duncansville, Pennsylvania, United States
• Low Country Rheumatology, PA /ID# 154198 — Summerville, South Carolina, United States
• West Tennessee Research Inst /ID# 148391 — Jackson, Tennessee, United States
• Arthritis Centers of Texas /ID# 152843 — Dallas, Texas, United States
• Royal Prince Alfred Hospital /ID# 154649 — Camperdown, New South Wales, Australia
• Optimus Clinical Research Pty. /ID# 133881 — Kogarah, New South Wales, Australia
• John Hunter Hospital /ID# 133884 — Newcastle, New South Wales, Australia
• Rheumatology Research Unit /ID# 133883 — Maroochydore, Queensland, Australia
• AKH Wien /ID# 133885 — Vienna, State of Vienna, Austria
• St. Joseph's Healthcare /ID# 149233 — Hamilton, Ontario, Canada
• The Arthritis Program Res Grp /ID# 129056 — Newmarket, Ontario, Canada
• Institut de Rhum. de Montreal /ID# 129055 — Montreal, Quebec, Canada
• Groupe de Recherche en Maladies Osseuses /ID# 129057 — Sainte-Foy, Quebec, Canada
• CIUSSS de l'Estrie - CHUS /ID# 144839 — Sherbrooke, Quebec, Canada
• CHU de la miletrie /ID# 133928 — Poitiers, Poitou-Charentes, France
• CHU Amiens Picardie /ID# 144846 — Amiens, Somme, France
• J Michael Grelier Research /ID# 149772 — Tuscaloosa, Alabama, United States

Full record on ClinicalTrials.gov

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