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A Study of Subjects With Rheumatoid Arthritis Who Are in Clinical Remission to Investigate Patient and Disease Characteristics That Could Help Identify Which Subjects Could Reduce Their Adalimumab Dose Without Flaring

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis; Musculoskeletal and Connective Tissue Diseases

Intervention: Adalimumab (Drug); Placebo (Other)

Phase: Phase 4

Status: Recruiting

Sponsored by: AbbVie

Official(s) and/or principal investigator(s):
Anabela Cardoso, MD, Study Director, Affiliation: AbbVie

Overall contact:
Rachel Weisberger, Phone: 847-938-3750, Email: rachel.weisberger@abbvie.com

Summary

A phase 4, multicenter, randomized, double-blind, parallel-group study in subjects with rheumatoid arthritis who are in stable clinical remission for at least 6 months and on treatment with adalimumab for at least 12 months in combination with methotrexate. After an open-label lead-in period of 4 weeks, subjects are randomized to a reduced dose of adalimumab or placebo and followed for 36 weeks. Subjects experiencing a flare will enter an open label rescue therapy arm with adalimumab normal dosing for 16 weeks. The study will investigate the correlation between Baseline subclinical inflammation and other assessed endpoints with flare occurence.

Clinical Details

Official title: 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 (PREDICTRA)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Hand and wrist synovitis rheumatoid arthritis magnetic resonance imaging (MRI) scoring system (RAMRIS) score

Bone Marrow Edema (BME) RAMRIS score

Composite of Hand, Wrist and BME RAMRIS scores

Flare occurrence

Secondary outcome:

Time to flare

Flare severity

Proportion of subjects who regain clinical remission in the Open-Label Rescue Arm over time

Time to regain clinical remission in the Open-Label Rescue Arm

Proportion of subjects who achieve low disease activity in the Open-Label Rescue Arm over time

Change in DAS28 (ESR)

Proportion of subjects maintaining clinical remission throughout the study

Change in MRI synovitis

Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) over time in the open-label rescue arm

Proportion of subjects with HAQ-DI normal

Change in RAPID 3 scores assessed during in-office visits

Change in RAPID 3 at home assessments

Change in Treatment Satisfaction Questionnaire for Medication (TSQM) in the open-label rescue arm

Change in Work Productivity and Activity Impairment (WPAI)

Change in Short Form-36 (SF-36)

Change in Functional Assessment of Chronic Illness Therapy - fatigue (FACIT-fatigue)

Clinical Disease Activity Index (CDAI)

Change in Simplified Disease Activity Index (SDAI)

Change in BME

Change in erosions RAMRIS scores

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Subject has 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). 2. Subject must meet the following criteria:

- Must be treated with adalimumab 40 mg sc eow for at least 12 months prior to

Screening Visit

- Must be treated with concomitant methotrexate (MTX) at a stable dose (oral or

sc at any dose) for at least 12 weeks prior to Screening Visit 3. Subject must be in sustained clinical remission based on the following:

- At least one documented disease activity score (DAS)28 Erythrocyte sedimentation

rate(ESR) or DAS28 c-reactive protein (CRP) < 2. 6 (or calculated based on documented components of the DAS28) in the patient chart 6 months or longer prior to the Screening Visit

- DAS28 (ESR) assessed at Screening < 2. 6, with all components including ESR

assessed at Screening. 4. If subjects are receiving concomitant conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) in addition to MTX, the dose must be stable for at least 12 weeks prior to the Screening Visit (e. g., chloroquine, hydroxychloroquine, sulfasalazine, gold formulations [including auranofin, gold sodium thiomalate, and aurothioglucose] and/or leflunomide). 5. If subjects are receiving concomitant oral corticosteroids, prednisone or equivalent must be < 10 mg/day and the dose must be stable for at least 4 weeks prior to the Screening Visit. 6. If subjects are receiving non-steroidal anti-inflammatory drugs (NSAIDs) the dose must be stable for at least 4 weeks prior to the Screening Visit. 7. Subject must be able and willing to provide written informed consent and comply with the requirements of this study protocol. Exclusion Criteria: 1. Any 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 2. Subject is 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). 3. Subject has been treated with intra-articular or parenteral corticosteroids within the last four weeks before Screening. 4. Subject has undergone joint surgery within 12 weeks of Screening (at joints to be assessed by magnetic resonance imaging (MRI) and/or ultrasound). 5. Subject has 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) 6. Subject has 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 0 mL/min/1. 73m2 at Screening, hepato-renal syndrome, severe chronic liver function impairment] 7. Subject has 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.

Locations and Contacts

Rachel Weisberger, Phone: 847-938-3750, Email: rachel.weisberger@abbvie.com

Site Reference ID/Investigator# 133881, Kogarah 2217, Australia; Recruiting
Site Reference ID/Investigator# 133881, Principal Investigator

Site Reference ID/Investigator# 133883, Maroochydore 4558, Australia; Recruiting
Site Reference ID/Investigator# 133883, Principal Investigator

Site Reference ID/Investigator# 133884, New Lambton Heights 2305, Australia; Recruiting
Site Reference ID/Investigator# 133884, Principal Investigator

Site Reference ID/Investigator# 129055, Montreal H2L 1S6, Canada; Recruiting
Site Reference ID/Investigator# 129055, Principal Investigator

Site Reference ID/Investigator# 129056, Newmarket L3Y 3R7, Canada; Recruiting
Site Reference ID/Investigator# 129056, Principal Investigator

Site Reference ID/Investigator# 129057, Quebec City G1V 3M7, Canada; Recruiting
Site Reference ID/Investigator# 129057, Principal Investigator

Site Reference ID/Investigator# 134708, Le Coudray 28630, France; Recruiting
Site Reference ID/Investigator# 134708, Principal Investigator

Site Reference ID/Investigator# 133928, Poitiers 86021, France; Recruiting
Site Reference ID/Investigator# 133928, Principal Investigator

Site Reference ID/Investigator# 129146, Bad Abbach 93077, Germany; Recruiting
Site Reference ID/Investigator# 129146, Principal Investigator

Site Reference ID/Investigator# 129143, Berlin-Buch 13125, Germany; Recruiting
Site Reference ID/Investigator# 129143, Principal Investigator

Site Reference ID/Investigator# 129142, Berlin 10117, Germany; Recruiting
Site Reference ID/Investigator# 129142, Principal Investigator

Site Reference ID/Investigator# 129147, Cologne Porz 51149, Germany; Recruiting
Site Reference ID/Investigator# 129147, Principal Investigator

Site Reference ID/Investigator# 129144, Munich 80336, Germany; Recruiting
Site Reference ID/Investigator# 129144, Principal Investigator

Site Reference ID/Investigator# 129148, Ratingen 40882, Germany; Recruiting
Site Reference ID/Investigator# 129148, Principal Investigator

Site Reference ID/Investigator# 134715, Debrecen 4032, Hungary; Recruiting
Site Reference ID/Investigator# 134715, Principal Investigator

Site Reference ID/Investigator# 129210, Dublin 4, Ireland; Not yet recruiting
Site Reference ID/Investigator# 129210, Principal Investigator

Site Reference ID/Investigator# 133932, Bari 70120, Italy; Recruiting
Site Reference ID/Investigator# 133932, Principal Investigator

Site Reference ID/Investigator# 132964, Milan 20122, Italy; Recruiting
Site Reference ID/Investigator# 132964, Principal Investigator

Site Reference ID/Investigator# 133886, Pavia 27100, Italy; Recruiting
Site Reference ID/Investigator# 133886, Principal Investigator

Site Reference ID/Investigator# 132895, Rome 00161, Italy; Recruiting
Site Reference ID/Investigator# 132895, Principal Investigator

Site Reference ID/Investigator# 132973, Verona 37134, Italy; Recruiting
Site Reference ID/Investigator# 132973, Principal Investigator

Site Reference ID/Investigator# 133887, Amsterdam 1056 AB, Netherlands; Recruiting
Site Reference ID/Investigator# 133887, Principal Investigator

Site Reference ID/Investigator# 132977, Nijmegen 6525 GA, Netherlands; Recruiting
Site Reference ID/Investigator# 132977, Principal Investigator

Site Reference ID/Investigator# 132896, Utrecht 3584 CX, Netherlands; Recruiting
Site Reference ID/Investigator# 132896, Principal Investigator

Site Reference ID/Investigator# 135529, Bilbao 48013, Spain; Recruiting
Site Reference ID/Investigator# 135529, Principal Investigator

Site Reference ID/Investigator# 137020, El Palmar, Murcia 30120, Spain; Recruiting
Site Reference ID/Investigator# 137020, Principal Investigator

Site Reference ID/Investigator# 133889, Madrid 28007, Spain; Recruiting
Site Reference ID/Investigator# 133889, Principal Investigator

Site Reference ID/Investigator# 134489, Madrid 28935, Spain; Recruiting
Site Reference ID/Investigator# 134489, Principal Investigator

Site Reference ID/Investigator# 135369, Madrid 28046, Spain; Recruiting
Site Reference ID/Investigator# 135369, Principal Investigator

Site Reference ID/Investigator# 135368, Sant Joan Despi, Barcelona 08970, Spain; Recruiting
Site Reference ID/Investigator# 135368, Principal Investigator

Site Reference ID/Investigator# 133890, Santiao de Compostela 15706, Spain; Recruiting
Site Reference ID/Investigator# 133890, Principal Investigator

Site Reference ID/Investigator# 134488, Valencia 46014, Spain; Recruiting
Site Reference ID/Investigator# 134488, Principal Investigator

Site Reference ID/Investigator# 133892, Vasteras 721 89, Sweden; Recruiting
Site Reference ID/Investigator# 133892, Principal Investigator

Site Reference ID/Investigator# 132966, Edinburghy EH4 2XU, United Kingdom; Recruiting
Site Reference ID/Investigator# 132966, Principal Investigator

Site Reference ID/Investigator# 129208, Leeds LS7 4SA, United Kingdom; Recruiting
Site Reference ID/Investigator# 129208, Principal Investigator

Site Reference ID/Investigator# 132980, Liverpool L9 7AL, United Kingdom; Recruiting
Site Reference ID/Investigator# 132980, Principal Investigator

Site Reference ID/Investigator# 133893, London E11 1NR, United Kingdom; Recruiting
Site Reference ID/Investigator# 133893, Principal Investigator

Site Reference ID/Investigator# 132982, Portsmouth P06 3LY, United Kingdom; Recruiting
Site Reference ID/Investigator# 132982, Principal Investigator

Site Reference ID/Investigator# 132965, Se1 9rt London, United Kingdom; Not yet recruiting
Site Reference ID/Investigator# 132965, Principal Investigator

Additional Information

Starting date: December 2014
Last updated: July 13, 2015

Page last updated: August 23, 2015

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