A Study in Patients with Rheumatoid Arthritis

• Conditions: Rheumatoid Arthritis; MedDRA version: 14.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2009-009696-34-DE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-14
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 648

Inclusion Criteria

Inclusion Criteria Common to Both Populations
[1]Ambulatory males or females, 18 years to 75 years, inclusive.
[1a] Male patients:
Agree to use a reliable method of birth control during the study.
[1b] Female patients:
Are women of childbearing potential who test negative for
pregnancy and agree to use a reliable method of birth control
during the study. Methods of contraception considered
acceptable are oral contraceptives, contraceptive patch,
intrauterine device, vaginal ring, diaphragm, or condom with
contraceptive gel.
OR
Are women who have undergone surgical sterilization
(hysterectomy, bilateral oophorectomy, or tubal ligation).
OR
Are post menopausal female patients defined as women
>45 years of age who have had a cessation of menses for at least
12 months OR are women between 40 and 45 years of age who
test negative for pregnancy, have had a cessation of menses for at
least 12 months, and have a Follicle Stimulating Hormone (FSH)
value >40 mIU/mL.
[2]RA diagnosis by American Rheumatism Association 1987 Revised Criteria.
[4]At least 6 tender and at least 6 swollen joints.
[5]C-reactive protein (CRP) >ULN or erythrocyte sedimentation rate (ESR) of at least 28 mm/hr.
Inclusion Criterion Specific to the bDMARD-naive Population
[6]Regular use of MTX for at least 12 weeks, and stable treatment (7.5 mg/week to 25 mg/week) for at least 8 weeks prior to baseline.
Inclusion Criterion Specific to the TNFa-IR Population
[7]TNFa-IR patients must have been treated at approved doses with at least 1 biologic TNFa inhibitor therapy and in the opinion of the investigator EITHER: a) had an insufficient response to at least 3 months of treatment (stopped due to insufficient efficacy), OR b) have been intolerant of such treatment, regardless of treatment duration.
[8] Regular use of at least 1 conventional DMARD in a stable treatment regimen as specified.
Some of the included criteria have been condensed from protocol language. Refer to protocol pages 39-40 for the full list and full text of all Inclusion/Exclusion Criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 68

Exclusion Criteria

Exclusion Criteria Specific to the bDMARD naive Population
[9]Have received any prior biologic DMARD therapy.
[10] Have had, in the opinion of the investigator, an inadequate response to
treatment with 5 or more conventional DMARDs (such as
leflunomide, azathioprine, cyclosporine, hydroxychloroquine, gold
salts, and sulfasalazine), prescribed alone or in combination, at
approved doses, for a minimum of 3 months.
[11] Use of DMARDs other than MTX, hydroxychloroquine, or
sulfasalazine (for example, gold salts, cyclosporine, azathioprine, or
any other immunosuppressives) in the 8 weeks prior to baseline.
[12]Use of leflunomide in the 12 weeks prior to baseline. Cholestyramine may be used to shorten the washout period from 12 to 4 weeks for leflunomide, if used according to standard protocol (Van Riel et al. 2004).
Exclusion Criteria Specific to the TNFa-IR Population
[13]Concurrent or recent use of any biologic DMARDs or biologic TNFa inhibitor therapies within specified washout periods.
Exclusion Criteria Common to Both Populations
[15]Concomitant use of NSAIDs in Part A, unless patient is on stable dose for at least 2 weeks prior to baseline.
[16]Parenteral glucocorticoid administered by intra-articular, intramuscular, or IV injection within 4 weeks of baseline, or for whom a parenteral injection of glucocorticosteroids is anticipated during the course of the study.
[17]Use of oral corticosteroids (at average daily doses of >10 mg/day of prednisone or its equivalent) or use of variable doses of oral corticosteroids within 4 weeks prior to baseline.
[18]Live vaccination within 12 weeks before baseline, or intend to have a live vaccination during the course of the study, or have participated in a vaccine clinical study within 12 weeks prior to baseline.
[19]Have a diagnosis of any systemic inflammatory condition other than RA, such as juvenile RA, seronegative spondyloarthropathy, Crohn’s disease, ulcerative colitis, psoriasis, or psoriatic arthritis.
[23] Have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease.
[24]Have findings, or a history of, clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders, which in the opinion of the investigator, place the patient at an unacceptable risk for participation in the study or of interfering with the interpretation of data.
[26]Serious bacterial infection within 3 months of entry, or a recent or ongoing infection that in the opinion of the investigator poses an unacceptable risk to participate in the study.
[27]Evidence or suspicion of active tuberculosis (TB) by medical history, physical examination, and/or chest radiograph or documentation of TB by a positive purified protein derivative (PPD) test.
Exceptions to this criterion include patients with latent TB, who have a documented treatment history with isoniazid (INH) for at least 6 months or a rifampicin-based regimen for at least 3 months; or patients who have received documented, completed, effective chemotherapy for active TB with no history of re-exposure since their treatment was completed; or patients with a history of BCG vaccination within the 10 years prior to baseline and who have a negative chest x-ray.
[28]Uncontr

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified