The purpose of this clinical trial is to assess the safety, efficacy, tolerability,
immunogenicity and pharmacokinetics of 3 dose levels of ART621 in the treatment of rheumatoid
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Full eligibility criteria for NCT00928317
Ages eligible for Study
18 Years to 80 Years
Genders eligible for Study
Accepts Healthy Volunteers
Provision of a valid written informed consent.
Male or female subjects ≥ 18 and ≤ 80 years old.
Women of childbearing potential, or men of fathering potential, must be using adequate
(in the investigator's opinion) birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilisation) during the study. Female subjects of childbearing potential must test negative for pregnancy prior to enrolling in the study. Post menopausal (cessation of menses for more than 2 years) women are eligible for this study.
Diagnosis of RA according to the revised (1987) American College of Rheumatology criteria for at least 6 months and no longer than 3 years prior to screening.
Meet ACR functional class criteria I, II or III.
Have active RA at the time of screening and at baseline, defined as ≥ 6 swollen joints and ≥ 6 tender joints (from 68 joint count) together with at least 2 of the following 3 criteria:
CRP level ≥ 1.5 mg/dl;
ESR by Westergren method ≥ 28 mm in the first hour; or
morning stiffness ≥ 45 minutes.
At least one of the following should be present at screening:
documented history or current presence of positive rheumatoid factor;
presence of serum anti-CCP antibodies; or
screening radiographic erosion
Have been tolerating concomitant methotrexate (oral or subcutaneous) for at least 3 months prior to screening and on a stable dose between 10-25 mg per week for at least 6 weeks prior to the first study dose. The route of administration must also be stable. Use of methotrexate dose of 25-50 mg every 2 weeks is also acceptable. (Other DMARDs taken concomitantly with methotrexate are not allowed. Those subjects concomitantly receiving additional DMARDs with methotrexate may enter the study by stopping the additional DMARD at least 4 weeks prior to first study dose).
If using the following medication, the subject must be on a stable dose for the 4 weeks prior to the first study dose and maintain that dose throughout the study:
oral corticosteroids, equivalent to ≤ 10 mg of prednisone/day.
one nonsteroidal anti-inflammatory drug (NSAID).
3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statins) or fibrates
(see Section 7.1 for acceptable doses).
Does not have active or latent TB according to eligibility assessment and screening rules (see Section 8.3.1).
Is willing and able to comply with study visits and other protocol requirements.
Pregnant, nursing, or planning a pregnancy (both men and women) within 9 months of enrolment.
Subjects weighing > 100 kgs.
Screening laboratory tests:
hemoglobin ≤ 8.0 gm/dl
white blood cells ≤ 3.0 x103 cells/µl
neutrophils ≤ 1.5 x 103 cells/µl
platelets ≤100 x 103 cells/µl
serum transaminase level (AST and ALT) ≥ 2 times upper limit of normal (ULN)
serum creatinine ≥ 0.15 mmol/l
Subjects with diagnosis of juvenile arthritis or other inflammatory or autoimmune diseases that might confound the evaluations of benefit from ART621 such as ankylosing spondylitis, systemic lupus erythematosus and Lyme disease.
Subjects who have previously failed to respond to any oral or injectable anti-TNFα therapy or subjects who have had to stop anti-TNFα therapy for safety reasons. Subjects who have successfully responded to anti-TNFα therapy in the past (but discontinued for reasons other than safety or lack of efficacy) > 6 months prior to study day one may enrol. Patients who have participated in a previous anti-TNFα therapy study are eligible if they are confirmed to have received placebo.
Subjects who have previously received the following anti-rheumatic drugs: interleukin-1 receptor antagonist [anakinra], rituximab, anti-CD4 antibody, abatacept, thalidomide, p38 MAP kinase inhibitor and other agents (other than those listed in Section 7.3).
Subjects who have undergone plasmapheresis within 6 months prior to randomisation.
Have received intraarticular, intramuscular, or intravenous corticosteroids, including intramuscular adrenocorticotropic hormone, during the 4 weeks prior to the first study dose, or non-stable doses of oral steroids.
Subjects with a history of any clinically significant adverse reaction to murine or chimeric proteins, including serious allergic reactions.
Subjects with Felty's syndrome or a history of Felty's syndrome.
Subjects who have received or are expecting to receive any live virus or bacterial vaccinations within 1 month before first study dose, during the study, or up to 3 months after the study dose.
Subjects with a history of, presence of, or at high risk of serious infection including:
history of active TB, or positive Mantoux test or QuantiFERON Gold test or chest x-ray suggestive of active or healed TB or positive contact history with a subject with active TB within the past 3 months. If subjects have a positive Mantoux test but a negative QuantiFERON Gold test, they may be enrolled.
a serious infection during the 3 months prior study entry (hospitalised or received IV antibiotics for an infection).
chronic or recurrent infectious disease.
systemic fungal infections
opportunistic infection within 3 months prior to screening (refer to 1993 CDC Classification System for HIV Infection).
subjects known, or suspected, to be infected with HIV, hepatitis B, or hepatitis C.
subjects with planned joint replacement surgery or a history of infected joint prosthesis or who have received antibiotics for a suspected infection of a joint prosthesis if that prosthesis has not been removed or replaced.
Subjects with a known history of demyelinating diseases such as multiple sclerosis or optic neuritis.
Subjects with evidence of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral disease.
Concurrent CHF, including medically controlled, asymptomatic CHF or ECG findings suggestive of CHF.
Subjects receiving cytotoxic drugs including cyclophosphamide, cyclosporine, or alkylating agents within 6 months prior to first study dose.
Known history or evidence of malignancy, lymphoproliferative or neoplastic disease with the exception of successfully treated basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia.
Subjects who have undergone organ transplant (with exception of a corneal transplant more than 3 months prior to screening).
Subjects previously enrolled in this study, currently participating in another investigational study or treated with any investigational drug within the previous 3 months or within 5 half-lives, whichever is greater, prior to first study dose.
Any other clinically significant disease or disorder or factors such as substance abuse which in the opinion of the investigator make the subject ineligible for participation in this study.
All locations for NCT00928317
United States (6)
Tampa Medical Group P.A.
Tampa, Florida, United States, 33614
Springfield, Illinois, United States, 62704
Physician Research Collaboration, LLC
Lincoln, Nebraska, United States, 68516
Westroads Medical Group
Omaha, Nebraska, United States, 68114
Arthritis Northwest, PLLC
Spokane, Washington, United States, 99204
Racine, Wisconsin, United States, 53142
Instituto Medico Especializado IME
Buenos Aires, BUE, Argentina, C1405BCH
Instituto Medico CER
Quilmes, Bue, Argentina, B1878DVB
ILAIM-CEOM Inst. Latinoamericano de Inv. Medicas
Cordoba, CRD, Argentina, X5000BNB
Sanatorio Parque S.A.
Rosario, SFE, Argentina, 2000
Rosario, SFE, Argentina, S2000PBJ
Ctro Polivalente de Asist e Invest Clinica CER
San Juan, SJN, Argentina, 5400
Centro Medico Privado de Reumatologia
San Miguel de Tucuman, TUC, Argentina, T4000AXL
Centro de Investigaciones Reumatológicas
Tucuman, TUC, Argentina, 4000
IMAI Research - Instituto Medico de Asistencia y Investigaci
Calle French, Argentina, 2673
Centro Medico Privado de Reumatologia
San Miguel de Tucuman, Argentina
Lyell McEwin Hospital
Elizabeth Vale, New South Wales, Australia, 5112
Georgetown Arthritis Centre
Sydney, New South Wales, Australia, 2298
Coast Joint Care
Maroochydore, Queensland, Australia, 4558
The Queen Elizabeth Hospital
Woodville, South Australia, Australia, 5011
Czech Republic (5)
Bruntal, Czech Republic, 79201
Jihlava, Czech Republic, 58633
ARTHROMED s. r. o.
Pardubice, Czech Republic, 53002
Fakultni nemocnice Plzen
Plzen - Bory, Czech Republic, 30599
Praha 2, Czech Republic, 12850
Apollo Hospital Educational and Research Foundation
Hyderabaad, Andh Prad, India, 500033
Nizams Institute of Medical Sciences
Hyderabaad, Andh Prad, India, 500082
Krishna Institute of Medical Sciences
Secunderabad, Andh Prad, India, 500003
King George Hospital
Vishakhapattanam, Andh Prad, India, 530002
St. John's Medical College Hospital
Bangalore, Karna, India, 560034
M.S. Ramaiah Memorial Hospital
Bangalore, Karna, India, 560054
Centre for Rheumatic Diseases
Pune, Mahara, India, 411001
Apollo Hospitals Educational and Research Foundation
Madurai, Tamilnadu, India, 625020
Sanjay Gandhi Postgraduate Institute
Lucknow, Uttar Prad, India, 226014
K. M. C. Hospital
Mangalore, India, 575001
Putra Medical Centre
Alor Setar, Kedah, Malaysia, 05100
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 50480
Perak, Malaysia, 30990
Sarawak General Hospital
Sarawak, Malaysia, 93586
New Zealand (1)
C G M Research Trust, The Princess Margaret Hospital
Christchurch, New Zealand, 8002
NZOZ Centrum Osteoporozy i Chorob Kostno-Stawowych
Bialystok, Poland, 15-461
Samodzielny Publiczny ZOZ w Dzialdowie
Dzialdowo, Poland, 13-200
Lublin, Poland, 20-607
Medyczne Centrum Hetmanska
Poznan, Poland, 60-218
SPSK nr 1 im. Tadeusza Sokolowskiego PAM
Szczecin, Poland, 71-252
Centrum Medyczne OSTEOMED
Warszawa, Poland, 02-341
View full eligibility
Tris trial is registered with FDA with number: NCT00928317. The sponsor of the trial is Arana Therapeutics Ltd and it is looking for 13 volunteers for the current phase.
Official trial title: Multi-Centre Randomised Double-Blind Pbo-Controlled Dose-Ranging Study to Evaluate the Safety, Tolerability, Efficacy, PK and Immunogenicity of Multiple Doses of ART621 for 3 Months in Patients With Rheumatoid Arthritis Taking Methotrexate
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