Rheumatoid ArthritisPhase 2NCT01063803
Study Evaluating Long-Term Safety Of ATN-103 In Subjects With Rheumatoid Arthritis
A Phase 2 study testing ATN-103 in people with Rheumatoid Arthritis, run by Ablynx, a Sanofi company at 67 sites in 8 countries.
Trial summary
This open-label extension study will allow subjects who have completed either the 3242K1-2000-WW or 3242K1-2001-JA study to receive up to an additional 48 weeks of ATN-103 treatment and will provide data on the long-term safety and tolerability of ATN-103 in subjects with rheumatoid arthritis. 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?
- ATN-103
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 67 sitesin 8 countries
- Study dates
- Feb 2010to Feb 2012
- 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
- Subjects must have completed study 3242K1-2000-WW or 3242K1-2001-JA and have had no events that, in the opinion of the investigator, would preclude entry or participation in this study.
Who cannot join
- Pregnant or nursing women.
- Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, cardiovascular, hematological, gastrointestinal, endocrine, pulmonary, immunologic [eg, Felty syndrome, human immunodeficiency virus (HIV) infection], infectious, neurological, or cerebral psychiatric disease, or evidence of demyelinating disease) that, in the investigator's judgment, will substantially increase the risk associated with the subject's developing an adverse event (AE) or serious adverse event (SAE) during the study, or preclude the evaluation of the subject's response.
Trial locations and contacts
67 sites in 8 countries.
67 sites in 8 countries
United States25 sites
Investigational Site
Birmingham, Alabama, 35216
Investigational Site
Bridgeport, Connecticut, 06606
Investigational Site
Charlotte, North Carolina, 28210
Investigational Site
Coeur d'Alene, Idaho, 83814
Investigational Site
Columbia, South Carolina, 29204
Investigational Site
Columbus, Ohio, 43213
Investigational Site
Dallas, Texas, 75231
Investigational Site
Frederick, Maryland, 21702
Investigational Site
Freehold, New Jersey, 07728
Investigational Site
Huntsville, Alabama, 35801
Investigational Site
Lake Oswego, Oregon, 97035
Investigational Site
Lansing, Michigan, 48910
Investigational Site
Myrtle Beach, South Carolina, 29572
Investigational Site
Nashville, Tennessee, 37205
Investigational Site
Newark, Delaware, 19713
Investigational Site
Ocala, Florida, 34474
Investigational Site
Oklahoma City, Oklahoma, 73103
Investigational Site
Peoria, Arizona, 85381
Investigational Site
Port Orange, Florida, 32127
Investigational Site
Riverside, California, 92501
Investigational Site
San Antonio, Texas, 78217
Investigational Site
Tulsa, Oklahoma, 74104
Investigational Site
Upland, California, 91786
Investigational Site
Vero Beach, Florida, 32960
Investigational Site
Winston-Salem, North Carolina, 27157
Japan19 sites
Investigational Site
Bunkyoucho, Matsuyama, Ehime
Investigational Site
Chuoh-ku, Fukuoka-shi, Fukuoka
Investigational Site
Higashi-tyo, Kawachi Nagano, Osaka
Investigational Site
Honmachi, Higashiyama, Kyoto
Investigational Site
Katō, Hyōgo
Investigational Site
Kawada-cho, Shinjyuku-ku, Tokyo
Investigational Site
Kawagoe, Saitama
Investigational Site
Kumamoto, Kumamoto
Investigational Site
Kurume, Fukuoka
Investigational Site
Midori-cho 2 Chome Tokorozawa-shi, Saitama
Investigational Site
Miyazaki, Miyazaki
Investigational Site
Nagano, Nagano
Investigational Site
Nitona-cho, Chuoh-ku, Chiba-shi, Chiba
Investigational Site
Shinanomachi, Shinjuku, Tokyo
Investigational Site
Takaoka-shi, Toyama
Investigational Site
Tohrimachi, Takasaki, Gunma
Investigational Site
Ureshino-machi, Ureshino-shi, Saga-ken
Investigational Site
Yamato, Sasebo, Nagasaki
Investigational Site
Yoshio-machi Iizuka-shi, Fukuoka
Russia8 sites
Investigational Site
Kemerovo, 650066
Investigational Site
Moscow, 115522
Investigational Site
Novosibirsk, 630008
Investigational Site
Orenburg, 460018
Investigational Site
Ryazan, 390026
Investigational Site
Vladimir, 600023
Investigational Site
Yaroslavl, 150003
Investigational Site
Yaroslavl, 150062
Canada5 sites
Investigational Site
Kitchener, Ontario, N2M 5N6
Investigational Site
Québec, Quebec, G1W 4R4
Investigational Site
St. Catharines, Ontario, L2N 7E4
Investigational Site
Toronto, Ontario, M9L 3A2
Investigational Site
Winnipeg, Manitoba, R3A 1M3
South Africa4 sites
Investigational Site
Berea, KwaZulu-Natal, 4001
Investigational Site
Les Marais, Gauteng, 0084
Investigational Site
Panorama, Western Cape, 7500
Investigational Site
Pinelands, Western Cape, 7405
Hungary3 sites
Investigational Site
Budapest, 1023
Investigational Site
Budapest, 1036
Investigational Site
Debrecen, 4032
Serbia2 sites
Investigational Site
Belgrade, Serbia, 11000
Investigational Site
Niška Banja, 18205
About this study
Official title: An Open-Label Extension Study To Assess The Long-term Safety And Tolerability Of ATN-103 In Subjects With Rheumatoid Arthritis
This open-label extension study will allow subjects who have completed either the 3242K1-2000-WW or 3242K1-2001-JA study to receive up to an additional 48 weeks of ATN-103 treatment and will provide data on the long-term safety and tolerability of ATN-103 in subjects with rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- ATN-103
- Keywords
- Open-label, Long-term safety study of ATN-103 in RA
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATN-103Drug
A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study)
ATN-103Drug
A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: ATN-103_30mg | Experimental | Not described Receives: Drug: ATN-103 |
| Arm 2: ATN-103_80 mg | Experimental | Not described Receives: Drug: ATN-103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of safety data and assessments will include adverse events, treatment-emergent adverse events, injection site reactions, infections, vital signs and safety laboratory measurements.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2012
- Study completionFeb 2012
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ablynx, a Sanofi company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Ablynx NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063803
- Sponsor's protocol ID
- 3242K1-2003
- Other IDs
- B2271005
- Status last verified
- Jan 2013
- First submitted
- 2 Feb 2010
- Last updated
- 11 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Study To Assess The Long-term Safety And Tolerability Of ATN-103 In Subjects With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01063803
- Acronym / sponsor ID
- 3242K1-2003
- Conditions
- Rheumatoid Arthritis
- Keywords
- Open-label, Long-term safety study of ATN-103 in RA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Ablynx, a Sanofi companyIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 5 Feb 2010 (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.
This open-label extension study will allow subjects who have completed either the 3242K1-2000-WW or 3242K1-2001-JA study to receive up to an additional 48 weeks of ATN-103 treatment and will provide data on the long-term safety and tolerability of ATN-103 in subjects with rheumatoid arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: ATN-103_30mg | Experimental | Drug: ATN-103 |
| Arm 2: ATN-103_80 mg | Experimental | Drug: ATN-103 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects must have completed study 3242K1-2000-WW or 3242K1-2001-JA and have had no events that, in the opinion of the investigator, would preclude entry or participation in this study.
Key exclusion criteria (2 listed)
- Pregnant or nursing women.
- Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, cardiovascular, hematological, gastrointestinal, endocrine, pulmonary, immunologic [eg, Felty syndrome, human immunodeficiency virus (HIV) infection], infectious, neurological, or cerebral psychiatric disease, or evidence of demyelinating disease) that, in the investigator's judgment, will substantially increase the risk associated with the subject's developing an adverse event (AE) or serious adverse event (SAE) during the study, or preclude the evaluation of the subject's response.
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 |
|---|---|---|
| ATN-103A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study) | Drug | Arm 1: ATN-103_30mg |
| ATN-103A single subcutaneous injection of ATN-103 every 4 weeks (approx 13 SC injections during the study) | Drug | Arm 2: ATN-103_80 mg |
Primary outcome
Collection of safety data and assessments will include adverse events, treatment-emergent adverse events, injection site reactions, infections, vital signs and safety laboratory measurements.
Time frame: 18 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 11 Apr 2016.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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.
Medical Director, MD study director
Ablynx NV
67 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATN-103 in people with Rheumatoid Arthritis, run by Ablynx, a Sanofi company at 67 sites in 8 countries.
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 1 inclusion and 2 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 11 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States, Japan, Russia, Canada, South Africa and 3 more countries. 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. 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?
Collection of safety data and assessments will include adverse events, treatment-emergent adverse events, injection site reactions, infections, vital signs and safety laboratory measurements. (time frame: 18 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 11 Apr 2016.