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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00785928
Registration number
NCT00785928
Ethics application status
Date submitted
3/11/2008
Date registered
5/11/2008
Date last updated
10/07/2018
Titles & IDs
Public title
A Study for Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy
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Scientific title
Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy
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Secondary ID [1]
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H9B-MC-BCDH
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Secondary ID [2]
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12409
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - LY2127399
Treatment: Drugs - Placebo
Experimental: Placebo -
Experimental: 1 mg LY2127399 -
Experimental: 3 mg LY2127399 -
Experimental: 10 mg LY2127399 -
Experimental: 30 mg LY2127399 -
Experimental: 60 mg LY2127399 -
Experimental: 120 mg LY2127399 -
Other interventions: LY2127399
Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Treatment: Drugs: Placebo
Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response up to 24 Weeks
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Assessment method [1]
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ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR50 Responder is defined as a participant with >50% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, participant global assessment, functional ability measure (Health Assessment Questionnaire-Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.
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Timepoint [1]
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Up to week 24
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Secondary outcome [1]
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Percentage of Participants Achieving The American College of Rheumatology (ACR)20 Response up to 24 Weeks
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Assessment method [1]
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ACR20 Responder Index is composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR20 Responder is defined as participant with at least 20% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, participant global assessment, functional ability measure (Health Assessment Questionnaire-Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.
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Timepoint [1]
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Up to 24 weeks
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Secondary outcome [2]
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Change From Baseline in the Tender Joint Count up to 24 Weeks
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Assessment method [2]
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Number of tender and painful joints was determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. Joints were assessed by pressure and joint manipulation on physical examination. Participant was asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both is translated into a single tender-versus-nontender dichotomy.
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Timepoint [2]
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Baseline, up to 24 weeks
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Secondary outcome [3]
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Change From Baseline in Swollen Joint Count up to 24 Weeks
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Assessment method [3]
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The number of swollen joints was determined by examination of 28 joints which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint.
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Timepoint [3]
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Baseline, up to 24 weeks
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Secondary outcome [4]
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Change From Baseline in the Disease Activity Score (DAS) up to 24 Weeks
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Assessment method [4]
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DAS (modified to include the 28 joint count [DAS28]) consists of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP), and participant global assessment of his or her disease activity (participant global visual analog scale [pt global VAS]). The DAS28 is calculated by using the following formula: DAS28-CRP = 0.56*sqrt(28TJC) + 0.28*sqrt(28SJC) + 0.36*ln(CRP+1) + 0.014*pt global VAS + 0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
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Timepoint [4]
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Baseline, up to 24 weeks
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Secondary outcome [5]
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Percentage of Participants With A European League Against Rheumatism Responder Index Based on the 28 Joint Count (EULAR28) up to 24 Weeks
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Assessment method [5]
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The EULAR28 categorizes clinical response based upon improvement since baseline in the Disease Activity Score (DAS) modified to include the 28 joint count (DAS28) and post-baseline DAS28 level. DAS28 consists of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP), and participant global assessment of their disease activity (participant global visual analog scale [VAS]). EULAR28 categories include: No Response (improvement in DAS28 of less than or equal to 0.6 units or post-baseline DAS28 score greater than 5.1 with improvement by less than or equal to 1.2 units), Moderate Response (post-baseline DAS28 score less than or equal to 5.1 with improvement by more than 0.6 units but no greater than 1.2 units or post-baseline DAS28 score greater than 3.2 with improvement by more than 1.2 units), and Good Response (post-baseline DAS28 score less than or equal to 3.2 with improvement by more than 1.2 units).
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Timepoint [5]
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Up to 24 weeks
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Secondary outcome [6]
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Change From Baseline in the Participant's Assessment of Joint Pain up to 24 Weeks
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Assessment method [6]
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Participant's assessment of joint pain using a visual analog scale (VAS), which ranged from 0 to 100 mm, where 0 indicated no pain and 100 indicated worst possible pain.
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Timepoint [6]
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Baseline, up to 24 weeks
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Secondary outcome [7]
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Change From Baseline in the Participant's Assessment of Disease Activity up to 24 Weeks
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Assessment method [7]
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Participant's assessment of disease activity using a visual analog scale (VAS), which ranged from 0 to 100 mm, where 0 indicated no arthritis activity and 100 indicated extremely active arthritis.
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Timepoint [7]
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Baseline, up to 24 weeks
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Secondary outcome [8]
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Change From Baseline in the Physician's Assessment of Disease Activity up to 24 Weeks
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Assessment method [8]
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Physician's assessment of disease activity using a visual analog scale (VAS) that ranged from 0 to 100 mm, where 0 indicated no arthritis activity and 100 indicated extremely active arthritis.
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Timepoint [8]
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Baseline, up to 24 weeks
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Secondary outcome [9]
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Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) up to 24 Weeks
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Assessment method [9]
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Participant's assessment of physical function. Disability section of questionnaire scores participant's self-perception on degree of difficulty (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do) when dressing and grooming, arising, eating, walking, hygiene, reach, grip, and performing other daily activities. Scores for each of the functional areas were averaged to calculate the functional disability index. The HAQ-DI total score, which is the average of the nonmissing functional scores, ranges from 0 (no disability) to 3 (severe disability).
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Timepoint [9]
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Baseline, up to 24 weeks
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Secondary outcome [10]
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Percent Change From Baseline in C-Reactive Protein (CRP) up to 24 Weeks
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Assessment method [10]
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Percent change = [(postbaseline CRP - baseline CRP)/baseline CRP]*100.
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Timepoint [10]
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Baseline, up to 24 weeks
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Secondary outcome [11]
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Change From Baseline in the Functional Assessment of Chronic Illness (FACIT) Fatigue Scale up to 24 Weeks
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Assessment method [11]
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The FACIT Fatigue Scale is a brief participant-reported measure of fatigue and consists of 13 items. Scores range from 0 to 52, with higher scores indicating less fatigue.
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Timepoint [11]
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Baseline, up to 24 weeks
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Secondary outcome [12]
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Change From Baseline in the Short Form Health Survey (SF-36) up to 24 Weeks
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Assessment method [12]
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A self-reported questionnaire that consists of 36 questions covering 8 health domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional, and general health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) and the physical component summary (PCS) have been constructed based on the 8 SF-36 domains. MCS and PCS scores = 0 to 100 (higher scores indicate better health status).
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Timepoint [12]
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Baseline, up to 24 weeks
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Secondary outcome [13]
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Pharmacokinetics of LY2127399: C-Trough Steady State Concentration at 24 Weeks
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Assessment method [13]
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C-trough is defined as the concentration of LY2127399 at the end of the dosing interval after the subcutaneous (sc) injection dosing once every 4 weeks. Mean C-trough value was obtained by conducting a simulation consisting of 1000 participants. The model was then used to predict the concentration-time profile at steady state. The pharmacokinetic (PK) parameters were then estimated from these concentration-time profiles.
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Timepoint [13]
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24 weeks
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Secondary outcome [14]
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Pharmacokinetics of LY2127399: T-Half Life (t1/2, Tau) at 24 Weeks
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Assessment method [14]
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T1/2,tau is defined as the apparent steady state elimination within the dosing interval. T1/2,tau was obtained by conducting a simulation consisting of 1000 participants. The model was then used to predict the concentration-time profile at steady state. The pharmacokinetic (PK) parameters were then estimated from these concentration-time profiles.
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Timepoint [14]
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24 weeks
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Secondary outcome [15]
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Change From Baseline in the Absolute Total B Cell (CD20+CD3- Cells) Count up to 24 Weeks
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Assessment method [15]
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B-lymphocyte antigen CD20 or CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B-cells. Total B cell counts (CD20+CD3-) are represented by the number of cells per microliter (cells/µL). The reference range is 43 - 602 cells/µL.
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Timepoint [15]
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Baseline, up to 24 weeks
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Secondary outcome [16]
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Change From Baseline in Serum Immunoglobulin up to 24 Weeks
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Assessment method [16]
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Serum immunoglobulin measured by Immunoglobulin G (IgG), Immunoglobulin M (IgM), and Immunoglobulin A (IgA) levels.
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Timepoint [16]
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Baseline, up to 24 weeks
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Secondary outcome [17]
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Number of Participants Experiencing An Adverse Event
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Assessment method [17]
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Serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section.
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Timepoint [17]
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Baseline up to 24 weeks
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Eligibility
Key inclusion criteria
- Have given written informed consent
- Women must not be at risk to become pregnant during study participation
- Diagnosis of Rheumatoid Arthritis (RA)
- Current, regular use of Methotrexate, at a stable dose
- Other criteria to be reviewed by study doctor
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Use of excluded medications(reviewed by study doctor)
- Have not failed biologic tumor necrosis factor-alpha (TNF-a) inhibitor therapy
- Have had recent or ongoing infection which, in the opinion of the study doctor put
patient at an unacceptable risk for participation in the study
- Evidence of tuberculosis
- Have systemic inflammatory condition other than RA, such as juvenile RA, Crohn's
disease, ulcerative colitis, psoriatic arthritis or seronegative spondyloarthropathy
- Other criteria to be reviewed by study doctor
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2010
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Sample size
Target
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Accrual to date
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Final
158
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Recruitment in Australia
Recruitment state(s)
QLD,SA
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Recruitment hospital [1]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Brisbane
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Recruitment hospital [2]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Maroochydore
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Recruitment hospital [3]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Elizabeth Vale
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Recruitment postcode(s) [1]
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4066 - Brisbane
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Recruitment postcode(s) [2]
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4558 - Maroochydore
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Recruitment postcode(s) [3]
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5112 - Elizabeth Vale
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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California
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United States of America
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Florida
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United States of America
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Pennsylvania
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United States of America
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Texas
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Argentina
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State/province [6]
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Buenos Aires
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Argentina
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Quilmes
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Chile
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Santiago
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Chile
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Valdivia
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Chile
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Vina Del Mar
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Germany
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Leipzig
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Hungary
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Budapest
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Hungary
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Esztergom
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Hungary
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Kistarcsa
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Hungary
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Szolnok
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India
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Hyderabaad
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India
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Lucknow
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India
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Pune
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India
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Secunderabad
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Mexico
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Chihuahua
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Mexico
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Cuernavaca
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Mexico
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Guadalajara
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Mexico
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Mexico City
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Mexico
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State/province [24]
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Monterrey
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Mexico
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San Luis Potosi
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Mexico
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Tampico
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Poland
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Bialystok
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Poland
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Chelm Slaski
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Poland
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Elblag
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Poland
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Krakow
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Poland
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Lubin
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Poland
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Lublin
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Poland
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Poznan
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Torun
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Poland
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Warsaw
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Poland
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Wroclaw
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Romania
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Brasov
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Romania
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Targu-Mures
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Slovakia
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Bratislava
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Slovakia
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Rimavska
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kiev
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Ukraine
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Odessa
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Ukraine
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State/province [44]
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Simferopol
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
To assess the efficacy of LY2127399 versus placebo using American College of Rheumatology
(ACR)50 response scale at 24 weeks
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00785928
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Call 1-877-CTLILLy (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST)
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Address
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Eli Lilly and Company
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00785928
Download to PDF