Rheumatoid ArthritisPhase 2NCT00854685
Dose Optimisation Study of ART621 in Subjects Diagnosed With Rheumatoid Arthritis Taking Methotrexate
A Phase 2 study testing ART621 in people with Rheumatoid Arthritis, run by Arana Therapeutics Ltd at 1 site in Sri Lanka.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- ART621
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteSri Lanka
- Study dates
- Feb 2009to Jan 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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 tests.
- Is willing and able to comply with study visits and other protocol requirements.
Who cannot join
- 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
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- 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.
- 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 patients 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, haematological, 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.
Trial locations and contacts
1 site in 1 country.
Sri Lanka1 site
Departement of Rheumatology, National Hospital Sri Lanka
Colombo
About this study
Official title: A Factorial-design, Randomised, Double-blind, Placebo-controlled, Dose Optimisation Study to Investigate the Safety, Efficacy, Immunogenicity and Pharmacokinetics of ART621 Following Multiple Dose Administration in Subjects Diagnosed With Rheumatoid Arthritis Concomitantly Taking Methotrexate
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.
Read the detailed description
Despite being effective in approximately 60% of subjects, there are limitations to existing anti-TNF therapies especially in relation to immunogenicity, safety and administration. In addition, due to their high molecular weight, currently marketed products are largely confined to the blood stream.
ART621 is an anti-TNF molecule that contains 2 identical domain "antibodies" that have the binding activity of a full antibody but with a substantially smaller molecular size. The molecular weight of approximately half that of full size antibodies is predicted to, a) have improved tissue penetration and, b) to be less immunogenic than full size antibodies.
This clinical trial is designed to establish the optimal dose level and dose frequency of ART621 in the treatment of patients with rheumatoid arthritis and to obtain data relating to the safety, immunogenicity and pharmacokinetics of ART621 when administered with an intravenous loading dose followed by subcutaneous administration every week compared to every fortnight.
- Conditions
- Rheumatoid Arthritis
- Being tested
- ART621, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ART621Drug
3.0mg/kg s.c. - weekly
ART621Drug
3.0mg/kg s.c. - fortnightly
ART621Drug
1.5mg/kg s.c. - weekly
ART621Drug
1.5mg/kg s.c. - fortnightly
PlaceboDrug
Placebo s.c. - weekly
PlaceboDrug
Placebo s.c. - fortnightly
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: ART621 |
| 2 | Experimental | Not described Receives: Drug: ART621 |
| 3 | Experimental | Not described Receives: Drug: ART621 |
| 4 | Experimental | Not described Receives: Drug: ART621 |
| 5 | Placebo comparator | Not described Receives: Drug: Placebo |
| 6 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of subcutaneous injections of ART621 (preceded by a single i.v. loading dose) at different dose frequencies
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arana Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Trident Clinical Research Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854685
- Sponsor's protocol ID
- ART621-223
- Status last verified
- Mar 2009
- First submitted
- 1 Mar 2009
- Last updated
- 6 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Factorial-design, Randomised, Double-blind, Placebo-controlled, Dose Optimisation Study to Investigate the Safety, Efficacy, Immunogenicity and Pharmacokinetics of ART621 Following Multiple Dose Administration in Subjects Diagnosed With Rheumatoid Arthritis Concomitantly Taking Methotrexate
- ClinicalTrials.gov ID
- NCT00854685
- Acronym / sponsor ID
- ART621-223
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Arana Therapeutics LtdIndustry (pharma, biotech, devices)
- Collaborators
- Trident Clinical Research Pty Ltd
- Study start
- Feb 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 3 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite being effective in approximately 60% of subjects, there are limitations to existing anti-TNF therapies especially in relation to immunogenicity, safety and administration. In addition, due to their high molecular weight, currently marketed products are largely confined to the blood stream.
ART621 is an anti-TNF molecule that contains 2 identical domain "antibodies" that have the binding activity of a full antibody but with a substantially smaller molecular size. The molecular weight of approximately half that of full size antibodies is predicted to, a) have improved tissue penetration and, b) to be less immunogenic than full size antibodies.
This clinical trial is designed to establish the optimal dose level and dose frequency of ART621 in the treatment of patients with rheumatoid arthritis and to obtain data relating to the safety, immunogenicity and pharmacokinetics of ART621 when administered with an intravenous loading dose followed by subcutaneous administration every week compared to every fortnight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (33 listed)
- Body weight >98 kg.
- Pregnant, nursing, or planning a pregnancy (both men and women) within 9 months of enrolment.
- Screening laboratory tests:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ART6213.0mg/kg s.c. - weekly | Drug | 1 |
| ART6213.0mg/kg s.c. - fortnightly | Drug | 2 |
| ART6211.5mg/kg s.c. - weekly | Drug | 3 |
| ART6211.5mg/kg s.c. - fortnightly | Drug | 4 |
| PlaceboPlacebo s.c. - weekly | Drug | 5 |
| PlaceboPlacebo s.c. - fortnightly | Drug | 6 |
Primary outcome
Safety and tolerability of subcutaneous injections of ART621 (preceded by a single i.v. loading dose) at different dose frequencies
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ART621 in people with Rheumatoid Arthritis, run by Arana Therapeutics Ltd at 1 site in Sri Lanka.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sri Lanka. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of subcutaneous injections of ART621 (preceded by a single i.v. loading dose) at different dose frequencies (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2010.