A Study for Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy

• ClinicalTrials.gov Identifier: NCT00785928
• Recruitment Status: Completed
• First Posted: November 5, 2008
• Results First Posted: July 10, 2018
• Last Update Posted: July 10, 2018
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Study Description

Brief Summary:

To assess the efficacy of LY2127399 versus placebo using American College of Rheumatology (ACR)50 response scale at 24 weeks

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis	Biological: LY2127399; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 158 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy
• Study Start Date: October 2008
• Actual Primary Completion Date: January 2010
• Actual Study Completion Date: December 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Placebo	Drug: Placebo; Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Experimental: 1 mg LY2127399	Biological: LY2127399; Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Experimental: 3 mg LY2127399	Biological: LY2127399; Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Experimental: 10 mg LY2127399	Biological: LY2127399; Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Experimental: 30 mg LY2127399	Biological: LY2127399; Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Experimental: 60 mg LY2127399	Biological: LY2127399; Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Experimental: 120 mg LY2127399	Biological: LY2127399; Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response up to 24 Weeks [ Time Frame: Up to week 24 ]
   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.

Secondary Outcome Measures :

1. Percentage of Participants Achieving The American College of Rheumatology (ACR)20 Response up to 24 Weeks [ Time Frame: Up to 24 weeks ]
   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.
2. Change From Baseline in the Tender Joint Count up to 24 Weeks [ Time Frame: Baseline, up to 24 weeks ]
   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.
3. Change From Baseline in Swollen Joint Count up to 24 Weeks [ Time Frame: Baseline, up to 24 weeks ]
   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.
4. Change From Baseline in the Disease Activity Score (DAS) up to 24 Weeks [ Time Frame: Baseline, up to 24 weeks ]
   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.
5. Percentage of Participants With A European League Against Rheumatism Responder Index Based on the 28 Joint Count (EULAR28) up to 24 Weeks [ Time Frame: Up to 24 weeks ]
   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).
6. Change From Baseline in the Participant's Assessment of Joint Pain up to 24 Weeks [ Time Frame: Baseline, up to 24 weeks ]
   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.
7. Change From Baseline in the Participant's Assessment of Disease Activity up to 24 Weeks [ Time Frame: Baseline, up to 24 weeks ]
   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.
8. Change From Baseline in the Physician's Assessment of Disease Activity up to 24 Weeks [ Time Frame: Baseline, up to 24 weeks ]
   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.
9. Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) up to 24 Weeks [ Time Frame: Baseline, up to 24 weeks ]
   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).
10. Percent Change From Baseline in C-Reactive Protein (CRP) up to 24 Weeks [ Time Frame: Baseline, up to 24 weeks ]
    Percent change = [(postbaseline CRP - baseline CRP)/baseline CRP]*100.
11. Change From Baseline in the Functional Assessment of Chronic Illness (FACIT) Fatigue Scale up to 24 Weeks [ Time Frame: Baseline, up to 24 weeks ]
    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.
12. Change From Baseline in the Short Form Health Survey (SF-36) up to 24 Weeks [ Time Frame: Baseline, up to 24 weeks ]
    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).
13. Pharmacokinetics of LY2127399: C-Trough Steady State Concentration at 24 Weeks [ Time Frame: 24 weeks ]
    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.
14. Pharmacokinetics of LY2127399: T-Half Life (t1/2, Tau) at 24 Weeks [ Time Frame: 24 weeks ]
    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.
15. Change From Baseline in the Absolute Total B Cell (CD20+CD3- Cells) Count up to 24 Weeks [ Time Frame: Baseline, up to 24 weeks ]
    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.
16. Change From Baseline in Serum Immunoglobulin up to 24 Weeks [ Time Frame: Baseline, up to 24 weeks ]
    Serum immunoglobulin measured by Immunoglobulin G (IgG), Immunoglobulin M (IgM), and Immunoglobulin A (IgA) levels.
17. Number of Participants Experiencing An Adverse Event [ Time Frame: Baseline up to 24 weeks ]
    Serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Exclusion Criteria:

• Use of excluded medications(reviewed by study doctor)
• Have not failed biologic tumor necrosis factor-alpha (TNF-α) 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

Contacts and Locations

Locations

United States, Alabama

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Huntsville, Alabama, United States, 35801

United States, California

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Calabasas, California, United States, 91302

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Upland, California, United States, 91786

United States, Florida

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Vero Beach, Florida, United States, 32960

United States, Pennsylvania

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Philadelphia, Pennsylvania, United States, 19152

United States, Texas

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Dallas, Texas, United States, 75235

Argentina

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Buenos Aires, Argentina, C1417EYG

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Quilmes, Argentina, 1878

Australia, Queensland

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Brisbane, Queensland, Australia, 4066

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Maroochydore, Queensland, Australia, 4558

Australia, South Australia

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Elizabeth Vale, South Australia, Australia, 5112

Chile

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Santiago, Chile

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Valdivia, Chile

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Vina Del Mar, Chile

Germany

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Leipzig, Germany, 04103

Hungary

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Budapest, Hungary, 1023

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Esztergom, Hungary, 2500

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Kistarcsa, Hungary, 2143

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Szolnok, Hungary, 5000

India

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Hyderabaad, India, 400082

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Lucknow, India, 226018

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Pune, India, 411001

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Secunderabad, India, 800003

Mexico

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Chihuahua, Mexico, 31000

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Cuernavaca, Mexico, 62270

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Guadalajara, Mexico, 44100

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Mexico City, Mexico, 06700

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Monterrey, Mexico, 64020

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San Luis Potosi, Mexico, 78210

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Tampico, Mexico, 89000

Poland

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Bialystok, Poland, 15-337

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Chelm Slaski, Poland, 41-403

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Elblag, Poland, 82-300

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Krakow, Poland, 30-510

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Lubin, Poland, 20-022

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Lublin, Poland, 20-954

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Poznan, Poland, 60-356

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Torun, Poland, 87-100

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Warsaw, Poland, 02-777

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Wroclaw, Poland, 50-088

Romania

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Brasov, Romania, 500365

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Targu-Mures, Romania, 540136

Slovakia

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Bratislava, Slovakia, 83103

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Rimavska, Slovakia, 97101

Ukraine

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Ivano-Frankivsk, Ukraine, 76018

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Kiev, Ukraine, 1601

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Odessa, Ukraine, 65027

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Simferopol, Ukraine, 95017

Sponsors and Collaborators

Eli Lilly and Company

Investigators

• Study Director: 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); Eli Lilly and Company

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Genovese MC, Lee E, Satterwhite J, Veenhuizen M, Disch D, Berclaz PY, Myers S, Sides G, Benichou O. A phase 2 dose-ranging study of subcutaneous tabalumab for the treatment of patients with active rheumatoid arthritis and an inadequate response to methotrexate. Ann Rheum Dis. 2013 Sep 1;72(9):1453-60. doi: 10.1136/annrheumdis-2012-202864. Epub 2013 Apr 18.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT00785928
• Other Study ID Numbers: 12409; H9B-MC-BCDH ( Other Identifier: Eli Lilly and Company )
• First Posted: November 5, 2008
• Results First Posted: July 10, 2018
• Last Update Posted: July 10, 2018
• Last Verified: June 2018

Keywords provided by Eli Lilly and Company:

Arthritis

Additional relevant MeSH terms:

Arthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases