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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)

Primary Purpose

Rheumatoid Arthritis, Musculoskeletal and Connective Tissue Diseases

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Adalimumab

Placebo

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Adalimumab, Taper, Flare, Arthritis, Anti-rheumatic drugs, Remission, Magnetic Resonance Imaging, Ultrasound, Biomarker, Drug Level, Reduced dose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Experimental

Arm Label

Adalimumab 40 mg eow

Adalimumab Tapering

Adalimumab Withdrawal Arm

Adalimumab 40 mg eow Rescue Arm

Arm Description

40 mg adalimumab administered subcutaneously every other week (eow) from Week 0 to Week 4 (Lead-in Period)

40 mg adalimumab administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)

Placebo administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)

40 mg adalimumab administered subcutaneously every other week from Flare Week 0 to Flare Week 16 (Open-label Rescue Period)

Outcomes

Primary Outcome Measures

Association Between Baseline Hand and Wrist Synovitis Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Score and Flare up to Week 40 in the Tapering Arm

Synovitis was assessed in three wrist regions (the distal radioulnar joint; the radiocarpal joint; the intercarpal and carpometacarpal joints) and in each Metacarpophalangeal joint (MCP) joint. The first carpometacarpal joint and the first MCP joint are not scored. The scale is 0-3. Score 0 is normal, and 1-3 (mild, moderate, severe) are by thirds of the presumed maximum volume of enhancing tissue in the synovial compartment. Flare is defined as an increase from Double-blind Baseline in DAS (Disease Activity Score) 28 erythrocyte sedimentation rate (ESR) of > 0.6 AND DAS28 [ESR] > 2.6, OR an increase in DAS28 (ESR) of ≥ 1.2 irrespective of the resulting DAS28 [ESR]. The association between baseline hand and wrist synovitis RAMRIS score and occurrence of rheumatoid arthritis flare up to Week 40 in the Tapering arm was examined using logistic regression, and the 95% confidence interval of the odds ratio was calculated.

Association Between Baseline Bone Marrow Edema RAMRIS Score and Flare up to Week 40 in the Tapering Arm

Bone marrow edema in each bone was scored separately. The scale is 0-3 based on the proportion of bone with edema, as follows-0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. Flare is defined as an increase from Double-blind Baseline in DAS (Disease Activity Score) 28 erythrocyte sedimentation rate (ESR) of > 0.6 AND DAS28 [ESR] > 2.6, OR an increase in DAS28 (ESR) of ≥ 1.2 irrespective of the resulting DAS28 [ESR]. The association between baseline bone marrow edema rheumatoid arthritis MRI scoring system (RAMRIS) score and occurrence of rheumatoid arthritis flare up to Week 40 in the Tapering arm was examined using logistic regression, and the 95% confidence interval of the odds ratio was calculated.

Association Between a Composite of Baseline Hand and Wrist Synovitis and Bone Marrow Edema RAMRIS Scores and Flare up to Week 40 in the Tapering Arm

The composite score is the sum of the baseline hand and wrist synovitis and bone marrow edema RAMRIS scores. Flare is defined as an increase from Double-blind Baseline in DAS (Disease Activity Score) 28 erythrocyte sedimentation rate (ESR) of > 0.6 AND DAS28 [ESR] > 2.6, OR an increase in DAS28 (ESR) of ≥ 1.2 irrespective of the resulting DAS28 [ESR]. The association between the composite baseline hand and wrist synovitis score and baseline bone marrow edema rheumatoid arthritis MRI scoring system (RAMRIS) score and occurrence of rheumatoid arthritis flare up to Week 40 in the Tapering arm was examined using logistic regression, and the 95% confidence interval of the odds ratio was calculated.

Secondary Outcome Measures

Median Time to Flare

Time to flare was defined as the number of weeks from the date of the first dose of study drug in the Double-blind period to the date of flare.

Physicians' Assessment of Flare Severity

Physicians rated the severity of flare at the Flare Week 0 visit from 0 (not severe) to 10 (very severe). The number of participants within each level of flare severity is presented.

Participants' Assessment of Flare Severity

Participants rated the severity of flare at the Flare Week 0 visit from 0 (not severe) to 10 (very severe). The number of participants within each level of flare severity is presented.

Percentage of Participants With a Flare

Flare was defined as an increase from Double-blind Baseline in DAS (Disease Activity Score) 28 erythrocyte sedimentation rate (ESR) of > 0.6 AND DAS28 [ESR] > 2.6, OR an increase in DAS28 (ESR) of ≥ 1.2 irrespective of the resulting DAS28 [ESR].

Number of Participants Who Regained Clinical Remission in the Open-Label Rescue Arm Over Time

The Disease Activity Score 28 (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR; mm/hour), and the participant's assessment of global disease activity (on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 (ESR) score. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. Clinical remission was defined as DAS28 (ESR) < 2.6.

Median Time to Clinical Remission From the Occurrence of Flare

Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28)

The Disease Activity Score 28 (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR; mm/hour), and the participant's assessment of global disease activity (on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 (ESR) score. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. Negative values indicate improvement from baseline.

Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score

The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76; higher scores indicate more disease activity. Negative values indicate improvement from the Double-blind baseline score.

Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score

The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein levels (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86; higher scores indicate more disease activity. Negative values indicate improvement from the Double-blind baseline score.

Number of Participants Maintaining Clinical Remission Defined By DAS28 (ESR) < 2.6, SDAI ≤ 3.3, and CDAI ≤ 2.8 at Each Visit By Treatment Arm

The maintenance of clinical remission after regaining remission during the Open-label rescue period was defined as either Disease Activity Score 28 (DAS28 ESR) < 2.6, Simplified Disease Activity Index (SDAI) score ≤ 3.3, or Clinical Disease Activity Index (CDAI) score ≤ 2.8).

Mean Change From Double-blind Baseline to Week 40 or Final Visit in Magnetic Resonance Imaging (MRI) Synovitis Score

Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Marrow Edema (BME) Score

Bone edema in each bone was scored separately. The scale is 0-3 based on the proportion of bone with edema, as follows-0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%.

Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Erosions Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Score

Bone erosions in each bone (wrists: carpal bones, distal radius, distal ulna, metacarpal bases; MCP joints: metacarpal heads, phalangeal bases) were scored separately. The scale is 0-10, based on the proportion of eroded bone compared to the ''assessed bone volume'', judged on all available images-0: no erosion; 1: 1-10% of bone eroded; 2; 11-20%, etc.

Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time

The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥ 0.22.

Number of Participants With Health Assessment Questionnaire- Disability Index (HAQ-DI) Score ≤ 0.5 at Double-blind Baseline and at Week 40

The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The number of participants with HAQ-DI score ≤ 0.5 (considered to be normal) was recorded.

Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits

The RAPID3 is an activity index derived from the Multi-dimensional Health Assessment Questionnaire (MD-HAQ). It includes an assessment of physical function, a pain Visual Analog Scale (VAS), and a participant global assessment of disease activity VAS. The total RAPID3 score ranges from 0 to 30 where higher scores represent severe disease. Negative values indicate improvement from the Double-blind baseline score.

Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home

Mean Change From Double-blind Baseline in Swollen Joint Count 28

Twenty-eight joints, excluding hip joints, were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with swelling) to 28 (worst possible score/28 joints with swelling). Negative values indicate improvement from baseline.

Mean Change From Double-blind Baseline in Swollen Joint Count 66

Sixty-six joints were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with swelling) to 66 (worst possible score/66 joints with swelling). Negative values indicate improvement from baseline.

Mean Change From Double-blind Baseline in Tender Joint Count 28

Twenty-eight joints were assessed for tenderness by physical examination. Pain or tenderness of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with tenderness) to 28 (worst possible score/28 joints with tenderness). Negative values indicate improvement from baseline.

Mean Change From Double-blind Baseline in Tender Joint Count 68

Sixty-eight joints were assessed for tenderness by physical examination. Pain or tenderness of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with tenderness) to 68 (worst possible score/68 joints with tenderness). Negative values indicate improvement from baseline.

Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity

Participants rated the severity of their rheumatoid arthritis symptoms and how well they were doing during the last 24 hours by placing a vertical mark on a line with a range of 0 (very well) to 100 mm (very poorly). Negative values indicate improvement from baseline.

Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain

Participants rated the severity of their rheumatoid arthritis pain in the past week by placing a vertical mark on a line with a range of 0 (no pain) to 100 mm (severe pain). Negative values indicate improvement from baseline.

Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity

Physicians assessed participants' current rheumatoid arthritis disease activity at the time of the visit (independent of the participant's self-assessment) by placing a vertical mark on a line with a range of 0 (very low) to 100 mm (very high). Negative values indicate improvement from baseline.

Mean Change From Double-blind Baseline in Morning Stiffness Duration

The duration of morning stiffness was reported by participants as the average daily length during the past week in minutes (from time of awaking to time of maximal improvement). Negative values indicate improvement from baseline.

Mean Change From Double-blind Baseline in Morning Stiffness Severity

Morning stiffness severity was assessed by a numeric rating-scale (NRS). Participants rated the severity of morning stiffness during the past week from 0 to 10 with 0 representing "not severe" and 10 "very severe". Negative values indicate improvement from baseline.

Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance

Participants rated the severity of their sleep disturbance in the past week by placing a vertical mark on a line with a range of 0 (sleep is no problem) to 100 mm (sleep is a major problem). Negative values indicate improvement from baseline.

Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score

Participants completed the 14-item Treatment Satisfaction Questionnaire for Medication (TSQM; Version 1.4) to assess satisfaction with their current rheumatoid arthritis treatment over the previous 2-3 weeks or since the last time that they took the medication. The TSQM consists of fourteen items over four domains (effectiveness, side effects, convenience, and global satisfaction). The 14 questions are answered either with yes/no or by means of a five or seven stage scale (ranging from very unsatisfied to satisfied). TSQM Scale scores for each domain range from 0 to 100 and higher scores represent higher satisfaction. Negative values indicate worsening from baseline.

Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score

Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score

Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score

Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores

The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in rheumatoid arthritis consisting of 6 questions, based on participant recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), overall work impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. A negative change from baseline indicates improvement.

Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Score

The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 scores for each domain and PCS/MCS range from 0-100: higher scores indicate a better state of health and a decrease from baseline represents worsening.

Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Mental Component Summary (MCS) Score

Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale

The FACIT-Fatigue questionnaire is a participant questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. A negative change from baseline indicates worsening.

Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP)

C-Reactive Protein (CRP; mg/L) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Negative values indicate improvement from baseline.

Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR)

Erythrocyte sedimentation rate (ESR; mm/hour) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. Negative values indicate improvement from baseline.

Full Information

NCT ID

NCT02198651

First Posted

July 22, 2014

Last Updated

June 6, 2019

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT02198651

Brief 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

Acronym

PREDICTRA

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

January 5, 2015 (Actual)

Primary Completion Date

May 3, 2018 (Actual)

Study Completion Date

August 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

This was a Phase 4, multicenter, randomized, double-blind, parallel-group study. The study included a Screening period of up to 28 days (unless extended with justification approved by study-designated physician), a 4-week Lead-In Period with open label (OL) 40 mg adalimumab administered subcutaneously (sc) every other week (eow), and a randomized 36-week double-blind period with 40 mg adalimumab sc every 3 weeks (q3wks; tapering arm) or placebo sc q3wks (withdrawal arm). Participants were randomized in a 5:1 ratio (tapering arm: withdrawal arm) after confirmation of meeting the disease activity score (DAS) criteria. Participants who experienced a protocol-defined flare at any time were to enter a rescue arm with OL 40 mg adalimumab administered sc eow for 16 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis, Musculoskeletal and Connective Tissue Diseases

Keywords

Rheumatoid Arthritis, Adalimumab, Taper, Flare, Arthritis, Anti-rheumatic drugs, Remission, Magnetic Resonance Imaging, Ultrasound, Biomarker, Drug Level, Reduced dose

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

149 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adalimumab 40 mg eow

Arm Type

Experimental

Arm Description

40 mg adalimumab administered subcutaneously every other week (eow) from Week 0 to Week 4 (Lead-in Period)

Arm Title

Adalimumab Tapering

Arm Type

Active Comparator

Arm Description

40 mg adalimumab administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)

Arm Title

Adalimumab Withdrawal Arm

Arm Type

Placebo Comparator

Arm Description

Placebo administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)

Arm Title

Adalimumab 40 mg eow Rescue Arm

Arm Type

Experimental

Arm Description

40 mg adalimumab administered subcutaneously every other week from Flare Week 0 to Flare Week 16 (Open-label Rescue Period)

Intervention Type

Biological

Intervention Name(s)

Adalimumab

Other Intervention Name(s)

ABT-D2E7, Humira

Intervention Description

Pre-filled syringe, administered by subcutaneous injection

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Pre-filled syringe, administered by subcutaneous injection in the Double-blind period

Primary Outcome Measure Information:

Title

Association Between Baseline Hand and Wrist Synovitis Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Score and Flare up to Week 40 in the Tapering Arm

Description

Time Frame

From Week 4 to Week 40

Title

Association Between Baseline Bone Marrow Edema RAMRIS Score and Flare up to Week 40 in the Tapering Arm

Description

Time Frame

From Week 4 to Week 40

Title

Association Between a Composite of Baseline Hand and Wrist Synovitis and Bone Marrow Edema RAMRIS Scores and Flare up to Week 40 in the Tapering Arm

Description

Time Frame

From Week 4 to Week 40

Secondary Outcome Measure Information:

Title

Median Time to Flare

Description

Time to flare was defined as the number of weeks from the date of the first dose of study drug in the Double-blind period to the date of flare.

Time Frame

From Week 4 to Week 40

Title

Physicians' Assessment of Flare Severity

Description

Physicians rated the severity of flare at the Flare Week 0 visit from 0 (not severe) to 10 (very severe). The number of participants within each level of flare severity is presented.

Time Frame

At the Flare Week 0 Visit

Title

Participants' Assessment of Flare Severity

Description

Participants rated the severity of flare at the Flare Week 0 visit from 0 (not severe) to 10 (very severe). The number of participants within each level of flare severity is presented.

Time Frame

At the Flare Week 0 Visit

Title

Percentage of Participants With a Flare

Description

Time Frame

From Week 4 to Week 40

Title

Number of Participants Who Regained Clinical Remission in the Open-Label Rescue Arm Over Time

Description

Time Frame

From Flare Week 0 to Flare Week 16

Title

Median Time to Clinical Remission From the Occurrence of Flare

Description

Time Frame

From Flare Week 0 to Flare Week 16

Title

Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28)

Description

The Disease Activity Score 28 (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR; mm/hour), and the participant's assessment of global disease activity (on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 (ESR) score. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. Negative values indicate improvement from baseline.

Time Frame

From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16

Title

Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score

Description

Time Frame

From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16

Title

Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score

Description

Time Frame

From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16

Title

Number of Participants Maintaining Clinical Remission Defined By DAS28 (ESR) < 2.6, SDAI ≤ 3.3, and CDAI ≤ 2.8 at Each Visit By Treatment Arm

Description

Time Frame

From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16

Title

Mean Change From Double-blind Baseline to Week 40 or Final Visit in Magnetic Resonance Imaging (MRI) Synovitis Score

Description

Time Frame

From Week 4 to Week 40 or Final visit

Title

Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Marrow Edema (BME) Score

Description

Time Frame

From Week 4 to Week 40 or Final visit

Title

Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Erosions Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Score

Description

Time Frame

From Week 4 to Week 40 or Final Visit

Title

Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time

Description

Time Frame

From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16

Title

Number of Participants With Health Assessment Questionnaire- Disability Index (HAQ-DI) Score ≤ 0.5 at Double-blind Baseline and at Week 40

Description

The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The number of participants with HAQ-DI score ≤ 0.5 (considered to be normal) was recorded.

Time Frame

Week 4 and Week 40

Title

Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits

Description

Time Frame

From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16

Title

Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home

Description

Time Frame

Flare Week 0 and Flare Weeks 1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15

Title

Mean Change From Double-blind Baseline in Swollen Joint Count 28

Description

Time Frame

From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16

Title

Mean Change From Double-blind Baseline in Swollen Joint Count 66

Description

Time Frame

From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16

Title

Mean Change From Double-blind Baseline in Tender Joint Count 28

Description

Time Frame

From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16

Title

Mean Change From Double-blind Baseline in Tender Joint Count 68

Description

Time Frame

From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16

Title

Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity

Description

Time Frame

From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16

Title

Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain

Description

Time Frame

From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16

Title

Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity

Description

Time Frame

From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16

Title

Mean Change From Double-blind Baseline in Morning Stiffness Duration

Description

Time Frame

From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16

Title

Mean Change From Double-blind Baseline in Morning Stiffness Severity

Description

Time Frame

From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16

Title

Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance

Description

Time Frame

From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16

Title

Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score

Description

Time Frame

At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16

Title

Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score

Description

Time Frame

At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16

Title

Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score

Description

Time Frame

At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16

Title

Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score

Description

Time Frame

At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16

Title

Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores

Description

Time Frame

At Weeks 4, 28, and 40 and Flare Weeks 0, 10, and 16

Title

Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Score

Description

Time Frame

At Weeks 4, 28, and 40 and from Flare Week 0 to Flare Week 16

Title

Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Mental Component Summary (MCS) Score

Description

Time Frame

At Weeks 4, 28, and 40 and from Flare Week 0 to Flare Week 16

Title

Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale

Description

Time Frame

At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16

Title

Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP)

Description

C-Reactive Protein (CRP; mg/L) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Negative values indicate improvement from baseline.

Time Frame

From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16

Title

Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR)

Description

Time Frame

From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AbbVie Inc.

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

J Michael Grelier Research /ID# 149772

City

Tuscaloosa

State/Province

Alabama

ZIP/Postal Code

35406

Country

United States

Facility Name

Westlake Medical Research (WMR) Clinical Trials /ID# 155386

City

Thousand Oaks

State/Province

California

ZIP/Postal Code

91360-3994

Country

United States

Facility Name

University of Florida /ID# 144851

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32209

Country

United States

Facility Name

North Georgia Rheumatology Grp /ID# 155225

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30045

Country

United States

Facility Name

The Arthritis & Diabetes Clinic, Inc. /ID# 149017

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71203

Country

United States

Facility Name

Aa Mrc Llc /Id# 151933

City

Grand Blanc

State/Province

Michigan

ZIP/Postal Code

48439

Country

United States

Facility Name

North Mississippi Med Clinics /ID# 149443

City

Tupelo

State/Province

Mississippi

ZIP/Postal Code

38801

Country

United States

Facility Name

Montefiore Medical Center /ID# 155013

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Shanahan Rheuma & Immuno /ID# 148689

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27617

Country

United States

Facility Name

Altoona Ctr Clinical Res /ID# 148448

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Low Country Rheumatology, PA /ID# 154198

City

Summerville

State/Province

South Carolina

ZIP/Postal Code

29486

Country

United States

Facility Name

West Tennessee Research Inst /ID# 148391

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

Arthritis Centers of Texas /ID# 152843

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Royal Prince Alfred Hospital /ID# 154649

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

Optimus Clinical Research Pty. /ID# 133881

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

John Hunter Hospital /ID# 133884

City

Newcastle

State/Province

New South Wales

ZIP/Postal Code

2305

Country

Australia

Facility Name

Rheumatology Research Unit /ID# 133883

City

Maroochydore

State/Province

Queensland

ZIP/Postal Code

4558

Country

Australia

Facility Name

AKH Wien /ID# 133885

City

Vienna

State/Province

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

St. Joseph's Healthcare /ID# 149233

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

Facility Name

The Arthritis Program Res Grp /ID# 129056

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 3R7

Country

Canada

Facility Name

Institut de Rhum. de Montreal /ID# 129055

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 1S6

Country

Canada

Facility Name

Groupe de Recherche en Maladies Osseuses /ID# 129057

City

Sainte-foy

State/Province

Quebec

ZIP/Postal Code

G1V 3M7

Country

Canada

Facility Name

CIUSSS de l'Estrie - CHUS /ID# 144839

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1G 2E8

Country

Canada

Facility Name

CHU de la miletrie /ID# 133928

City

Poitiers

State/Province

Poitou-Charentes

ZIP/Postal Code

86021

Country

France

Facility Name

CHU Amiens Picardie /ID# 144846

City

Amiens CEDEX 1

State/Province

Somme

ZIP/Postal Code

80054

Country

France

Facility Name

Hospital Louis Pasteur /ID# 134708

City

Chartres

ZIP/Postal Code

28630

Country

France

Facility Name

CHU de Grenoble - Albet Michal /ID# 135953

City

Grenoble

ZIP/Postal Code

38043

Country

France

Facility Name

Asklepios Klinik /ID# 129146

City

Bad Abbach

ZIP/Postal Code

93077

Country

Germany

Facility Name

Immanuel-Krankenhaus /ID# 129143

City

Berlin-buch

ZIP/Postal Code

13125

Country

Germany

Facility Name

Charité Universitätsmedizin Campus Mitte /ID# 129142

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Krankenhaus Porz am Rhein /ID# 129147

City

Cologne

ZIP/Postal Code

51149

Country

Germany

Facility Name

Rheumaforschungszentrum II /ID# 148554

City

Hamburg

ZIP/Postal Code

20095

Country

Germany

Facility Name

Klinikum der Univ Munich /ID# 129144

City

Munich

ZIP/Postal Code

80337

Country

Germany

Facility Name

Rheumazentrum Ratingen /ID# 129148

City

Ratingen

ZIP/Postal Code

40882

Country

Germany

Facility Name

Rheumatologische Praxis /ID# 151979

City

Rendsburg

ZIP/Postal Code

24768

Country

Germany

Facility Name

University General Hospital "Attikon" /ID# 134709

City

Athens

State/Province

Attiki

ZIP/Postal Code

12462

Country

Greece

Facility Name

General Hospital of Athens /ID# 129202

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

General UH of Heraklion /ID# 134712

City

Heraklion

ZIP/Postal Code

71110

Country

Greece

Facility Name

Budai Irgalmasrendi Korhaz /ID# 134714

City

Budapest

ZIP/Postal Code

1023

Country

Hungary

Facility Name

Orszagos Reumatologiai es Fizi /ID# 134710

City

Budapest

ZIP/Postal Code

1023

Country

Hungary

Facility Name

Debreceni Egyetem Klinikai Koz /ID# 134715

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

St Vincent's University Hosp /ID# 129210

City

Dublin

ZIP/Postal Code

D04 T6F4

Country

Ireland

Facility Name

AP Romano Umberto I /ID# 132895

City

Rome

State/Province

Lazio

ZIP/Postal Code

00161

Country

Italy

Facility Name

A.O. Univ Consorziale Policlin /ID# 133932

City

Bari

ZIP/Postal Code

70124

Country

Italy

Facility Name

Azienda Istituto Gaetano Pini /ID# 132964

City

Milan

ZIP/Postal Code

20122

Country

Italy

Facility Name

Fondazione IRCCS Policlinico /ID# 133886

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

A.O.U.I. di Verona Policlinico /ID# 132973

City

Verona

ZIP/Postal Code

37134

Country

Italy

Facility Name

Jan van Breemen Instituut /ID# 133887

City

Amsterdam

ZIP/Postal Code

1056 AB

Country

Netherlands

Facility Name

Rijnstate Hospital /ID# 129206

City

Arnhem

ZIP/Postal Code

6815 AD

Country

Netherlands

Facility Name

Medisch Centrum Leeuwarden /ID# 133888

City

Leeuwarden

ZIP/Postal Code

8934 AD

Country

Netherlands

Facility Name

UMC Utrecht /ID# 132896

City

Utrecht

ZIP/Postal Code

3584 CX

Country

Netherlands

Facility Name

Hospital Parc de Salut del Mar /ID# 148670

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Hosp Sant J. Despi-Moises Brog /ID# 135368

City

Barcelona

ZIP/Postal Code

08906

Country

Spain

Facility Name

Hospital Universitario Basurto /ID# 135529

City

Bilbao

ZIP/Postal Code

48013

Country

Spain

Facility Name

Hosp Clinico Virgen Arrixaca /ID# 137020

City

El Palmar

ZIP/Postal Code

30120

Country

Spain

Facility Name

Hospital General Universitario Gregorio Maranon /ID# 133889

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Hospital Universitario La Paz /ID# 135369

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Hospital Univ De Mostoles /ID# 134489

City

Mostoles

ZIP/Postal Code

28935

Country

Spain

Facility Name

Complejo Hosp Santiago /ID# 133890

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Hosp General Univ de Valencia /ID# 134488

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Facility Name

Akademiska Sjukhuset /ID# 148669

City

Uppsala

State/Province

Uppsala Lan

ZIP/Postal Code

751 85

Country

Sweden

Facility Name

Uppsala University Hospital /ID# 133891

City

Uppsala

ZIP/Postal Code

75185

Country

Sweden

Facility Name

Vastmanlands Sjukhus /ID# 133892

City

Vasteras

ZIP/Postal Code

72189

Country

Sweden

Facility Name

Whipps Cross Univ Hospital /ID# 133893

City

London

State/Province

London, City Of

ZIP/Postal Code

E11 1NR

Country

United Kingdom

Facility Name

Guy's and St Thomas' NHS Found /ID# 132965

City

London

State/Province

London, City Of

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Mid Essex Hospitals NHS Trust /ID# 151636

City

Chelmsford

ZIP/Postal Code

CM1 7ET

Country

United Kingdom

Facility Name

Western General Hospital /ID# 132966

City

Edinburgh

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Facility Name

Chapel Allerton Hospital /ID# 129208

City

Leeds

ZIP/Postal Code

LS7 4SA

Country

United Kingdom

Facility Name

University Hospital Aintree /ID# 132980

City

Liverpool

ZIP/Postal Code

L9 7AL

Country

United Kingdom

Facility Name

Queen Alexandra Hospital /ID# 132982

City

Portsmouth

ZIP/Postal Code

PO6 3LY

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

IPD Sharing URL

https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

Citations:

PubMed Identifier

32404343

Citation

Emery P, Burmester GR, Naredo E, Sinigaglia L, Lagunes I, Koenigsbauer F, Conaghan PG. Adalimumab dose tapering in patients with rheumatoid arthritis who are in long-standing clinical remission: results of the phase IV PREDICTRA study. Ann Rheum Dis. 2020 Aug;79(8):1023-1030. doi: 10.1136/annrheumdis-2020-217246. Epub 2020 May 13.

Results Reference

derived

PubMed Identifier

29490959

Citation

Emery P, Burmester GR, Naredo E, Zhou Y, Hojnik M, Conaghan PG. Design of a phase IV randomised, double-blind, placebo-controlled 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) patients (PREDICTRA). BMJ Open. 2018 Feb 28;8(2):e019007. doi: 10.1136/bmjopen-2017-019007.

Results Reference

derived

Links:

URL

https://www.rxabbvie.com/

Description

Related Info

Learn more about this trial

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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)

Rheumatoid Arthritis, Musculoskeletal and Connective Tissue Diseases

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial