Rheumatoid ArthritisPhase 1NCT01853033
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-122 in Subjects With Rheumatoid Arthritis
A Phase 1 study testing ABT-122 in people with Rheumatoid Arthritis, run by AbbVie at 4 sites in United States.
Trial summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of ABT-122 in subjects with Rheumatoid Arthritis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- ABT-122
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2013to May 2014
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Rheumatoid Arthritis (RA) > 3 months.
- On methotrexate (MTX) therapy => 3 months and on a stable dose for at least 4 weeks.
- Except for MTX, must have discontinued all disease-modifying antirheumatic drugs (DMARDs) for at least 3 months or 5 half-lives, whichever is longer.
- Body Mass Index (BMI) is 19 to 38, inclusive.
- Other than RA, subjects should be in good general health.
Who cannot join
- Evidence of anti-ABT-122 antibody on a serum sample taken at Screening.
- History of significant allergic reaction; or history of anaphylactic reaction to any agent; or history of major reaction to any IgG containing product.
- History of persistent chronic or active infection(s) requiring hospitalization or treatment with intravenous or oral anti-microbials/antibiotics within the past 30 days.
- History or evidence of active tuberculosis (TB) or the subject has evidence of risk factor for latent TB.
- Subject has any medical condition or illness other than RA that is not well controlled with treatment.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Site Reference ID/Investigator# 100780
Dallas, Texas, 75231
Site Reference ID/Investigator# 118964
Duncansville, Pennsylvania, 16635
Site Reference ID/Investigator# 108655
Lenexa, Kansas, 66219
Site Reference ID/Investigator# 107115
Raleigh, North Carolina, 27612
About this study
Official title: A Study in Patients With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ABT-122
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of ABT-122 in subjects with Rheumatoid Arthritis.
Read the detailed description
This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study. Twenty-four subjects with Rheumatoid Arthritis will be selected to participate. Subjects will be randomized to receive either ABT-122 or placebo. ABT-122 or placebo will be administered as subcutaneous (under the skin) injections in three dosing groups.
- Conditions
- Rheumatoid Arthritis
- Being tested
- ABT-122, Placebo
- Keywords
- Tolerability, Immunogenicity, Safety, Rheumatoid Arthritis, Pharmacokinetics
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-122Biological
Injection
PlaceboBiological
Placebo Injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Randomized 6 drug/2 placebo by group Receives: Biological: ABT-122; Biological: Placebo |
| Group 2 | Experimental | Randomized 6 drug/2 placebo by group Receives: Biological: ABT-122; Biological: Placebo |
| Group 3 | Experimental | Randomized 6 drug/2 placebo by group Receives: Biological: ABT-122; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events
Collect all adverse events at each visit
Measured: From date of first dose of ABT-122 until 42 days after the last dose of ABT-122
Change in physical exam including vital signs
Blood pressure, pulse and body temperature
Measured: From date of first dose of ABT-122 until 42 days after last dose of ABT-122
Change in clinical lab test results
Hematology, Chemistry, and Urinalysis
Measured: From date of first dose of ABT-122 until 42 days after the last dose of ABT-122
Change in Electrocardiogram (ECG) results
ECGs done in triplicate
Measured: From subject's baseline (prior to subject's first dose) and up to 168 hours following the last dose of study drug
Determination of pharmacokinetic (PK) parameters
Cmax, Tmax, AUC, elimination rate constant and half-life
Measured: Prior to first dose up to 42 days after the last dose of ABT-122
Secondary outcomes (1)
Measurement of anti-drug anti-bodies (ADA) of ABT-122
Measurement of ADA
Measured: Prior to each dose and up until 42 days after the last dose of ABT-122
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study startJul 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Padley, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853033
- Sponsor's protocol ID
- M14-048
- Status last verified
- Jun 2014
- First submitted
- 10 May 2013
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Khatri A, Goss S, Jiang P, Mansikka H, Othman AA. Pharmacokinetics of ABT-122, a TNF-alpha- and IL-17A-Targeted Dual-Variable Domain Immunoglobulin, in Healthy Subjects and Patients with Rheumatoid Arthritis: Results from Three Phase I Trials. Clin Pharmacokinet. 2018 May;57(5):613-623. doi: 10.1007/s40262-017-0580-y.
PubMed 28744796Fleischmann RM, Wagner F, Kivitz AJ, Mansikka HT, Khan N, Othman AA, Khatri A, Hong F, Jiang P, Ruzek M, Padley RJ. Safety, Tolerability, and Pharmacodynamics of ABT-122, a Tumor Necrosis Factor- and Interleukin-17-Targeted Dual Variable Domain Immunoglobulin, in Patients With Rheumatoid Arthritis. Arthritis Rheumatol. 2017 Dec;69(12):2283-2291. doi: 10.1002/art.40319. Epub 2017 Nov 8.
PubMed 28941216
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study in Patients With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ABT-122
- ClinicalTrials.gov ID
- NCT01853033
- Acronym / sponsor ID
- M14-048
- Conditions
- Rheumatoid Arthritis
- Keywords
- Tolerability, Immunogenicity, Safety, Rheumatoid Arthritis, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 14 May 2013 (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 assess the safety, tolerability and pharmacokinetics of ABT-122 in subjects with Rheumatoid Arthritis.
Detailed description
This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study. Twenty-four subjects with Rheumatoid Arthritis will be selected to participate. Subjects will be randomized to receive either ABT-122 or placebo. ABT-122 or placebo will be administered as subcutaneous (under the skin) injections in three dosing groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: ABT-122, Biological: PlaceboRandomized 6 drug/2 placebo by group |
| Group 2 | Experimental | Biological: ABT-122, Biological: PlaceboRandomized 6 drug/2 placebo by group |
| Group 3 | Experimental | Biological: ABT-122, Biological: PlaceboRandomized 6 drug/2 placebo by group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Rheumatoid Arthritis (RA) > 3 months.
- On methotrexate (MTX) therapy => 3 months and on a stable dose for at least 4 weeks.
- Except for MTX, must have discontinued all disease-modifying antirheumatic drugs (DMARDs) for at least 3 months or 5 half-lives, whichever is longer.
- Body Mass Index (BMI) is 19 to 38, inclusive.
- Other than RA, subjects should be in good general health.
Key exclusion criteria (5 listed)
- Evidence of anti-ABT-122 antibody on a serum sample taken at Screening.
- History of significant allergic reaction; or history of anaphylactic reaction to any agent; or history of major reaction to any IgG containing product.
- History of persistent chronic or active infection(s) requiring hospitalization or treatment with intravenous or oral anti-microbials/antibiotics within the past 30 days.
- History or evidence of active tuberculosis (TB) or the subject has evidence of risk factor for latent TB.
- Subject has any medical condition or illness other than RA that is not well controlled with treatment.
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 |
|---|---|---|
| ABT-122Injection | Biological | Group 1, Group 2, Group 3 |
| PlaceboPlacebo Injection | Biological | Group 1, Group 2, Group 3 |
Primary outcome
Number of participants with Adverse Events
Time frame: From date of first dose of ABT-122 until 42 days after the last dose of ABT-122
Collect all adverse events at each visit
Change in physical exam including vital signs
Time frame: From date of first dose of ABT-122 until 42 days after last dose of ABT-122
Blood pressure, pulse and body temperature
Change in clinical lab test results
Time frame: From date of first dose of ABT-122 until 42 days after the last dose of ABT-122
Hematology, Chemistry, and Urinalysis
Change in Electrocardiogram (ECG) results
Time frame: From subject's baseline (prior to subject's first dose) and up to 168 hours following the last dose of study drug
ECGs done in triplicate
Determination of pharmacokinetic (PK) parameters
Time frame: Prior to first dose up to 42 days after the last dose of ABT-122
Cmax, Tmax, AUC, elimination rate constant and half-life
1 secondary outcome
Measurement of anti-drug anti-bodies (ADA) of ABT-122
Time frame: Prior to each dose and up until 42 days after the last dose of ABT-122
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 20 Nov 2017.
- Results publication: PubMed 28744796Khatri A, Goss S, Jiang P, Mansikka H, Othman AA. Pharmacokinetics of ABT-122, a TNF-alpha- and IL-17A-Targeted Dual-Variable Domain Immunoglobulin, in Healthy Subjects and Patients with Rheumatoid Arthritis: Results from Three Phase I Trials. Clin Pharmacokinet. 2018 May;57(5):613-623. doi: 10.1007/s40262-017-0580-y.
- Derived from this study: PubMed 28941216Fleischmann RM, Wagner F, Kivitz AJ, Mansikka HT, Khan N, Othman AA, Khatri A, Hong F, Jiang P, Ruzek M, Padley RJ. Safety, Tolerability, and Pharmacodynamics of ABT-122, a Tumor Necrosis Factor- and Interleukin-17-Targeted Dual Variable Domain Immunoglobulin, in Patients With Rheumatoid Arthritis. Arthritis Rheumatol. 2017 Dec;69(12):2283-2291. doi: 10.1002/art.40319. Epub 2017 Nov 8.
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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.
Robert Padley, MD study director
AbbVie
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABT-122 in people with Rheumatoid Arthritis, run by AbbVie at 4 sites in United States.
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 5 inclusion and 5 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 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 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.
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?
Number of participants with Adverse Events (time frame: From date of first dose of ABT-122 until 42 days after the last dose of ABT-122). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01853033, which also lists 2 linked publications.
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 20 Nov 2017.