Dose Optimisation Study of ART621 in Subjects Diagnosed With Rheumatoid Arthritis Taking Methotrexate

NCT00854685 | Completed Phase 2 DMC

• 1 other identifier: ART621-223
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to establish what dose level and dosing frequency is optimal in the treatment of rheumatoid arthritis patients with ART621.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of subcutaneous injections of ART621 (preceded by a single i.v. loading dose) at different dose frequencies

  3 months

Study Arms (6)

1

EXPERIMENTAL

Drug: ART621

2

EXPERIMENTAL

Drug: ART621

3

EXPERIMENTAL

Drug: ART621

4

EXPERIMENTAL

Drug: ART621

5

PLACEBO COMPARATOR

Drug: Placebo

6

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ART621 DRUG

3.0mg/kg s.c. - weekly

1

Placebo DRUG

Placebo s.c. - weekly

5

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are willing to give signed informed consent..
• Male or female subjects at least 18 years of age and no more than 80 years of age.
• Women of childbearing potential, or men of reproductive 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 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:

You may not qualify if:

• Body weight \>98 kg.
• Pregnant, nursing, or planning a pregnancy (both men and women) within 9 months of enrolment.
• Screening laboratory tests:
• haemoglobin ≤ 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 a 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-TNF 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-TNF 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.

Sponsors & Collaborators

• Arana Therapeutics Ltd: lead
• Trident Clinical Research Pty Ltd: collaborator

Study Sites (1)

Departement of Rheumatology, National Hospital Sri Lanka

Colombo, Sri Lanka

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 1, 2009
• First Posted: March 3, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: January 6, 2010

Record last verified: 2009-03

Locations

SR (1)