Active Rheumatoid ArthritisPhase 1/2NCT00959036
Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis
A Phase 1/2 study testing ATN-103 and Methotrexate in people with Active Rheumatoid Arthritis, run by Ablynx, a Sanofi company at 67 sites in 9 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of ATN-103 when administered to subjects with active rheumatoid arthritis compared with placebo. All subjects must be on a stable dose and route of methotrexate. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Active Rheumatoid Arthritis
- What is being tested?
- ATN-103 and Methotrexate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 67 sitesin 9 countries
- Study dates
- Sep 2009to Jan 2011
- Phase
- Phase 1/2
- 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
- Clinical diagnosis of active rheumatoid arthritis on a stable background of methotrexate (7.5-25 mg weekly).
Who cannot join
- Any significant health problem other than rheumatoid arthritis
- Any clinically significant laboratory abnormalities
- Any prior use of B cell-depleting therapy
Trial locations and contacts
67 sites in 9 countries.
67 sites in 9 countries
United States37 sites
Investigational Site
Albuquerque, New Mexico, 87108
Investigational Site
Allentown, Pennsylvania, 18103
Investigational Site
Birmingham, Alabama, 35209
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, 75235
Investigational Site
Frederick, Maryland, 21702
Investigational Site
Freehold, New Jersey, 07728
Investigational Site
Hickory, North Carolina, 28601
Investigational Site
Houston, Texas, 77004
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Huntsville, Alabama, 35801
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Lake Mary, Florida, 32746
Investigational Site
Lake Oswego, Oregon, 97035
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Lansing, Michigan, 48910
Investigational Site
Mineola, New York, 11501
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
Oklahoma City, Oklahoma, 73139
Investigational Site
Orlando, Florida, 32804
Investigational Site
Peoria, Arizona, 85381
Investigational Site
Port Orange, Florida, 32127
Investigational Site
Riverside, California, 92501
Investigational Site
San Antonio, Texas, 78217
Investigational Site
Scottsdale, Arizona, 85258
Investigational Site
Tacoma, Washington, 98405
Investigational Site
Tulsa, Oklahoma, 74104
Investigational Site
Upland, California, 91786
Investigational Site
Vero Beach, Florida, 32960
Investigational Site
West Yarmouth, Massachusetts, 12672
Investigational Site
Winston-Salem, North Carolina, 27103
Investigational Site
Winston-Salem, North Carolina, 27157
Russia11 sites
Investigational Site
Kemerovo, 650061
Investigational Site
Moscow, 113811
Investigational Site
Moscow, 119049
Investigational Site
Novosibirsk, 630047
Investigational Site
Novosibirsk, 630091
Investigational Site
Orenburg, 460000
Investigational Site
Petrozavodsk, 185019
Investigational Site
Ryazan, 390026
Investigational Site
Vladimir, 600023
Investigational Site
Yaroslavl, 150003
Investigational Site
Yaroslavl, 150062
Canada6 sites
Investigational Site
Kitchener, Ontario, N2M 5N6
Investigational Site
Ottawa, Ontario, K1H 1A2
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
Cape Town, 7405
Investigational Site
Cape Town, 7500
Investigational Site
Pretoria, 0181
Belgium2 sites
Investigational Site
Brussels, Belgium, 1200
Investigational Site
Leuven, 3000
Hungary2 sites
Investigational Site
Budapest, 1027
Investigational Site
Debrecen, 4012
Serbia2 sites
Investigational Site
Belgrade, Serbia, 11000
Investigational Site
Niška Banja, 18205
Switzerland2 sites
Investigational Site
Chur, 7000
Investigational Site
Zurich, Canton of Zurich, 8091
About this study
Official title: A Seamless, Phase 1/2, Multiple Ascending Dose, Proof Of Concept Study Of ATN-103 Administered To Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate
The purpose of this study is to evaluate the safety and efficacy of ATN-103 when administered to subjects with active rheumatoid arthritis compared with placebo. All subjects must be on a stable dose and route of methotrexate.
- Conditions
- Active Rheumatoid Arthritis
- Being tested
- ATN-103, Placebo, Methotrexate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATN-103Drug
10 mg every 4 weeks until week 12
ATN-103Drug
10 mg every 8 weeks until week 12
ATN-103Drug
30 mg every 4 weeks until week 12
ATN-103Drug
80 mg every 4 weeks until week 12
ATN-103Drug
80 mg every 8 weeks until week 12
PlaceboDrug
Placebo every 4 weeks
MethotrexateDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Experimental | ATN-103 10 mg every 4 weeks until week 12 Receives: Drug: ATN-103; Drug: Methotrexate |
| Treatment Group 2 | Experimental | ATN-103 10 mg every 8 weeks until week 12 Receives: Drug: ATN-103; Drug: Methotrexate |
| Treatment Group 3 | Experimental | ATN-103 30 mg every 4 weeks until week 12 Receives: Drug: ATN-103; Drug: Methotrexate |
| Treatment Group 4 | Experimental | ATN-103 80 mg every 4 weeks until week 12 Receives: Drug: ATN-103; Drug: Methotrexate |
| Treatment Group 5 | Experimental | ATN-103 80 mg every 8 weeks until week 12 Receives: Drug: ATN-103; Drug: Methotrexate |
| Treatment Group 6 | Placebo comparator | Placebo every 4 weeks Receives: Drug: Placebo; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
American College of Rheumatology (ACR) 20 response at week 16
Measured: 6 months
Secondary outcomes (1)
Additional efficacy endpoints as measured by the number of swollen and tender joints, physician and patient global assessments of disease activity, ACR responses, DAS28, EULAR, and Health Outcome Assessments
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ablynx, a Sanofi company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Josefin-Beate Holz, MD, Study director, Ablynx, a Sanofi company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959036
- Sponsor's protocol ID
- 3242K1-2000
- Other IDs
- B2271003
- Status last verified
- Jan 2013
- First submitted
- 13 Aug 2009
- Last updated
- 30 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Seamless, Phase 1/2, Multiple Ascending Dose, Proof Of Concept Study Of ATN-103 Administered To Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate
- ClinicalTrials.gov ID
- NCT00959036
- Acronym / sponsor ID
- 3242K1-2000
- Conditions
- Active Rheumatoid Arthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Ablynx, a Sanofi companyIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 14 Aug 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 study is to evaluate the safety and efficacy of ATN-103 when administered to subjects with active rheumatoid arthritis compared with placebo. All subjects must be on a stable dose and route of methotrexate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Experimental | Drug: ATN-103, Drug: MethotrexateATN-103 10 mg every 4 weeks until week 12 |
| Treatment Group 2 | Experimental | Drug: ATN-103, Drug: MethotrexateATN-103 10 mg every 8 weeks until week 12 |
| Treatment Group 3 | Experimental | Drug: ATN-103, Drug: MethotrexateATN-103 30 mg every 4 weeks until week 12 |
| Treatment Group 4 | Experimental | Drug: ATN-103, Drug: MethotrexateATN-103 80 mg every 4 weeks until week 12 |
| Treatment Group 5 | Experimental | Drug: ATN-103, Drug: MethotrexateATN-103 80 mg every 8 weeks until week 12 |
| Treatment Group 6 | Placebo comparator | Drug: Placebo, Drug: MethotrexatePlacebo every 4 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of active rheumatoid arthritis on a stable background of methotrexate (7.5-25 mg weekly).
Key exclusion criteria (3 listed)
- Any significant health problem other than rheumatoid arthritis
- Any clinically significant laboratory abnormalities
- Any prior use of B cell-depleting therapy
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-10310 mg every 4 weeks until week 12 | Drug | Treatment Group 1 |
| ATN-10310 mg every 8 weeks until week 12 | Drug | Treatment Group 2 |
| ATN-10330 mg every 4 weeks until week 12 | Drug | Treatment Group 3 |
| ATN-10380 mg every 4 weeks until week 12 | Drug | Treatment Group 4 |
| ATN-10380 mg every 8 weeks until week 12 | Drug | Treatment Group 5 |
| PlaceboPlacebo every 4 weeks | Drug | Treatment Group 6 |
| Methotrexate | Drug | Treatment Group 1, Treatment Group 2, Treatment Group 3, Treatment Group 4, Treatment Group 5, Treatment Group 6 |
Primary outcome
American College of Rheumatology (ACR) 20 response at week 16
Time frame: 6 months
1 secondary outcome
Additional efficacy endpoints as measured by the number of swollen and tender joints, physician and patient global assessments of disease activity, ACR responses, DAS28, EULAR, and Health Outcome Assessments
Time frame: 6 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 30 Jan 2013.
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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.
Josefin-Beate Holz, MD study director
Ablynx, a Sanofi company
67 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ATN-103 and Methotrexate in people with Active Rheumatoid Arthritis, run by Ablynx, a Sanofi company at 67 sites in 9 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 3 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 30 Jan 2013. 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, Russia, Canada, South Africa, Belgium and 4 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
American College of Rheumatology (ACR) 20 response at week 16 (time frame: 6 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 30 Jan 2013.