Rheumatoid Arthritis (RA)Phase 2NCT03823391
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)
A Phase 2 study testing ABBV-3373 and Adalimumab in people with Rheumatoid Arthritis (RA), run by AbbVie at 30 sites in 7 countries.
Trial summary
This study will assess the safety, tolerability, and efficacy of ABBV-3373 in participants with moderately to severely active rheumatoid arthritis (RA) on background methotrexate (MTX) compared with adalimumab. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- ABBV-3373 and Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 30 sitesin 7 countries
- Study dates
- 27 Mar 2019to 26 Aug 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participant has the clinical diagnosis of RA for > 3 months based on the 1987 American College of Rheumatology (ACR) classification criteria or 2010 ACR/European League against Rheumatism (EULAR) criteria.
- Participant meets the following disease activity criteria: >= 4 swollen joints (based on 28 joint count) and >= 4 tender joints (based on 28 joint count) at Screening and Baseline visits and disease activity score (28 joints) (DAS28) C-reactive protein (CRP) >= 3.2 at Screening.
- Participant has an incomplete response to methotrexate. Participants must have been on oral or parental MTX therapy >= 3 months and on a stable prescription of 15 to 25 mg/week (or >= 10 mg/week in participants intolerant of MTX at doses >= 15 mg/week) for >= 4 weeks prior to the first dose of study drug. Participant must be expected to be able to continue on stable dose of MTX for the duration of study participation.
Who cannot join
- Participants previously exposed to adalimumab or other anti-tumor necrosis factor (TNF) biologics.
- Participants previously exposed to non-anti-TNF biologics or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) for RA, with exception of participants exposed for less than 3 months and terminated not due to lack of efficacy or intolerability.
Trial locations and contacts
30 sites in 7 countries.
30 sites in 7 countries
United States18 sites
PCCR Solution /ID# 215457
Colleyville, Texas, 76034
Duke Early Phase Research Unit (DCRI) /ID# 213212
Durham, North Carolina, 27710
C.V. Mehta MD, Med Corporation /ID# 213068
Hemet, California, 92543
Rheum Assoc of North Alabama /ID# 213626
Huntsville, Alabama, 35801
Institute of Arthritis Researc /ID# 213043
Idaho Falls, Idaho, 83404
West Tennessee Research Inst /ID# 208838
Jackson, Tennessee, 38305
Paramount Medical Research Con /ID# 209042
Middleburg Heights, Ohio, 44130
Suncoast Clinical Research /ID# 213973
New Port Richey, Florida, 34652
Arthritis Center, Inc. /ID# 213972
Palm Harbor, Florida, 34684
AZ Arthritis and Rheum Researc /ID# 208515
Phoenix, Arizona, 85032
Trinity Universal Research Association /ID# 209167
Plano, Texas, 75024-5283
Clinvest Research LLC /ID# 215451
Springfield, Missouri, 65810-2607
W. Broward Rheum Assoc Inc. /ID# 211017
Tamarac, Florida, 33321
BayCare Medical Group, Inc. /ID# 213935
Tampa, Florida, 33614-7101
Robin K. Dore MD, Inc /ID# 213045
Tustin, California, 92780
Inland Rheum & Osteo Med Grp /ID# 213044
Upland, California, 91786
STAT Research, Inc. /ID# 213933
Vandalia, Ohio, 45377-9464
PRN Professional Research Network of Kansas, LLC /ID# 213046
Wichita, Kansas, 67205
Hungary4 sites
DRC Gyogyszervizsgalo Kozpont Kft. /ID# 210159
Balatonfüred, Veszprém megye, 8230
Budai Irgalmasrendi Korhaz /ID# 208877
Budapest, 1023
Debreceni Egyetem Klinikai Kozpont /ID# 210164
Debrecen, 4032
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 210055
Miskolc, Borsod-Abauj Zemplen county, 3529
Israel2 sites
Rambam Health Care Campus /ID# 212747
Haifa, 3109601
Sheba Medical Center /ID# 211339
Ramat Gan, 5239424
Poland2 sites
SANUS Szpital Specjalistyczny /ID# 209022
Stalowa Wola, 37-450
Reumatika - Centrum Reumatologii NZOZ /ID# 209220
Warsaw, 02-691
Puerto Rico2 sites
GCM Medical Group, PSC /ID# 208154
San Juan, 00909
Mindful Medical Research /ID# 208403
San Juan, 00918-3756
Netherlands1 site
Academisch Medical center Amsterdam /ID# 209303
Amsterdam, North Holland, 1105 AZ
About this study
Official title: A Randomized, Double-Blind, Double-Dummy, Active Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Subjects With Moderate to Severe Rheumatoid Arthritis
This study will assess the safety, tolerability, and efficacy of ABBV-3373 in participants with moderately to severely active rheumatoid arthritis (RA) on background methotrexate (MTX) compared with adalimumab.
Read the detailed description
This study consists of a 12-week double-blind active-controlled phase and a 12 week double-blind extension period.
In the active-controlled period of the first 12 weeks of treatment, participants are randomized to receive either ABBV-3373 100 mg intravenously (IV) every other week (EOW) or adalimumab 80 mg subcutaneously (SC) EOW according to a 2:1 ratio.
At Week 12, the administration of ABBV-3373 was to stop to assess the durability of the observed clinical effects up to 24 weeks. Participants randomized to ABBV-3373 were to receive placebo injections, whereas participants randomized into the adalimumab arm were to continue their 80 mg dosing.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- ABBV-3373, Placebo for ABBV-3373, Adalimumab, Placebo for adalimumab
- Keywords
- Rheumatoid Arthritis (RA), ABBV-3373, Adalimumab
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-3373Drug
ABBV-3373 is administered as intravenous (IV) infusion
Placebo for ABBV-3373Drug
Placebo for ABBV-3373 is administered as IV infusion
AdalimumabDrug
Also called Humira
Adalimumab is administered as subcutaneous (SC) injection
Placebo for adalimumabDrug
Placebo for adalimumab is administered as subcutaneous (SC) injection
| Study group | Role | What they receive |
|---|---|---|
| ABBV-3373 Followed by Placebo | Experimental | Participants will be administered with 100 mg ABBV-3373 by intravenous infusion and placebo to adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive placebo to adalimumab every other week until Week 22. Receives: Drug: ABBV-3373; Drug: Placebo for adalimumab |
| Adalimumab | Experimental | Participants will be administered with placebo to ABBV-3373 by intravenous infusion and 80 mg adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive 80 mg adalimumab subcutaneously every other week until Week 22. Receives: Drug: Placebo for ABBV-3373; Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 12 in Disease Activity Score (DAS) 28 (C-reactive Protein [CRP])
The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a visual analog scale [VAS] from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Measured: Baseline and Week 12
Secondary outcomes (5)
Change From Baseline to Week 12 in Clinical Disease Activity Index (CDAI)
The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.
Measured: Baseline and Week 12
Change From Baseline in Simplified Disease Activity Index (SDAI)
The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0-10 cm and level of CRP (in mg/dL; normal < 1 mg/dL). The SDAI has a range from 0 to 86, with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.
Measured: Baseline and Week 12
Change From Baseline to Week 12 in DAS28 (Erythrocyte Sedimentation Rate [ESR])
The DAS28 (ESR) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and ESR (in mm/hr). Scores on the DAS28 (ESR) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline indicates improvement in disease activity.
Measured: Baseline and Week 12
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12
The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A DAS28 (CRP) score less than or equal to 3.2 indicates low disease activity.
Measured: Week 12
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
- ≥ 50% improvement in 68-tender joint count;
- ≥ 50% improvement in 66-swollen joint count; and
- ≥ 50% improvement in at least 3 of the 5 following parameters:
- Physician global assessment of disease activity
- Patient global assessment of disease activity
- Patient assessment of pain
- Health Assessment Questionnaire - Disability Index (HAQ-DI)
- High-sensitivity C-reactive protein (hsCRP).
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start27 Mar 2019
- Primary completion8 Apr 2020
- Study completion26 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid Arthritis (RA)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823391
- Sponsor's protocol ID
- M16-560
- Other IDs
- 2018-003053-21, 2018
- Status last verified
- Jun 2021
- First submitted
- 29 Jan 2019
- Last updated
- 19 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Publications
Buttgereit F, Aelion J, Rojkovich B, Zubrzycka-Sienkiewicz A, Chen S, Yang Y, Arikan D, D'Cunha R, Pang Y, Kupper H, Radstake T, Amital H. Efficacy and Safety of ABBV-3373, a Novel Anti-Tumor Necrosis Factor Glucocorticoid Receptor Modulator Antibody-Drug Conjugate, in Adults with Moderate-to-Severe Rheumatoid Arthritis Despite Methotrexate Therapy: A Randomized, Double-Blind, Active-Controlled Proof-of-Concept Phase IIa Trial. Arthritis Rheumatol. 2023 Jun;75(6):879-889. doi: 10.1002/art.42415. Epub 2023 Apr 2.
PubMed 36512671
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Double-Dummy, Active Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Subjects With Moderate to Severe Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03823391
- Acronym / sponsor ID
- M16-560
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Rheumatoid Arthritis (RA), ABBV-3373, Adalimumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 8 Apr 2020 (actual)
- Study completion
- 26 Aug 2020 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Posted 19 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety, tolerability, and efficacy of ABBV-3373 in participants with moderately to severely active rheumatoid arthritis (RA) on background methotrexate (MTX) compared with adalimumab.
Detailed description
This study consists of a 12-week double-blind active-controlled phase and a 12 week double-blind extension period.
In the active-controlled period of the first 12 weeks of treatment, participants are randomized to receive either ABBV-3373 100 mg intravenously (IV) every other week (EOW) or adalimumab 80 mg subcutaneously (SC) EOW according to a 2:1 ratio.
At Week 12, the administration of ABBV-3373 was to stop to assess the durability of the observed clinical effects up to 24 weeks. Participants randomized to ABBV-3373 were to receive placebo injections, whereas participants randomized into the adalimumab arm were to continue their 80 mg dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABBV-3373 Followed by Placebo | Experimental | Drug: ABBV-3373, Drug: Placebo for adalimumabParticipants will be administered with 100 mg ABBV-3373 by intravenous infusion and placebo to adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive placebo to adalimumab every other week until Week 22. |
| Adalimumab | Experimental | Drug: Placebo for ABBV-3373, Drug: AdalimumabParticipants will be administered with placebo to ABBV-3373 by intravenous infusion and 80 mg adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive 80 mg adalimumab subcutaneously every other week until Week 22. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant has the clinical diagnosis of RA for > 3 months based on the 1987 American College of Rheumatology (ACR) classification criteria or 2010 ACR/European League against Rheumatism (EULAR) criteria.
- Participant meets the following disease activity criteria: >= 4 swollen joints (based on 28 joint count) and >= 4 tender joints (based on 28 joint count) at Screening and Baseline visits and disease activity score (28 joints) (DAS28) C-reactive protein (CRP) >= 3.2 at Screening.
- Participant has an incomplete response to methotrexate. Participants must have been on oral or parental MTX therapy >= 3 months and on a stable prescription of 15 to 25 mg/week (or >= 10 mg/week in participants intolerant of MTX at doses >= 15 mg/week) for >= 4 weeks prior to the first dose of study drug. Participant must be expected to be able to continue on stable dose of MTX for the duration of study participation.
Key exclusion criteria (2 listed)
- Participants previously exposed to adalimumab or other anti-tumor necrosis factor (TNF) biologics.
- Participants previously exposed to non-anti-TNF biologics or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) for RA, with exception of participants exposed for less than 3 months and terminated not due to lack of efficacy or intolerability.
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 |
|---|---|---|
| ABBV-3373ABBV-3373 is administered as intravenous (IV) infusion | Drug | ABBV-3373 Followed by Placebo |
| Placebo for ABBV-3373Placebo for ABBV-3373 is administered as IV infusion | Drug | Adalimumab |
| AdalimumabAlso: HumiraAdalimumab is administered as subcutaneous (SC) injection | Drug | Adalimumab |
| Placebo for adalimumabPlacebo for adalimumab is administered as subcutaneous (SC) injection | Drug | ABBV-3373 Followed by Placebo |
Primary outcome
Change From Baseline to Week 12 in Disease Activity Score (DAS) 28 (C-reactive Protein [CRP])
Time frame: Baseline and Week 12
The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a visual analog scale [VAS] from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
5 secondary outcomes
Change From Baseline to Week 12 in Clinical Disease Activity Index (CDAI)
Time frame: Baseline and Week 12
Change From Baseline in Simplified Disease Activity Index (SDAI)
Time frame: Baseline and Week 12
Change From Baseline to Week 12 in DAS28 (Erythrocyte Sedimentation Rate [ESR])
Time frame: Baseline and Week 12
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12
Time frame: Week 12
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
Time frame: Baseline and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36512671Buttgereit F, Aelion J, Rojkovich B, Zubrzycka-Sienkiewicz A, Chen S, Yang Y, Arikan D, D'Cunha R, Pang Y, Kupper H, Radstake T, Amital H. Efficacy and Safety of ABBV-3373, a Novel Anti-Tumor Necrosis Factor Glucocorticoid Receptor Modulator Antibody-Drug Conjugate, in Adults with Moderate-to-Severe Rheumatoid Arthritis Despite Methotrexate Therapy: A Randomized, Double-Blind, Active-Controlled Proof-of-Concept Phase IIa Trial. Arthritis Rheumatol. 2023 Jun;75(6):879-889. doi: 10.1002/art.42415. Epub 2023 Apr 2.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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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.
AbbVie Inc. study director
AbbVie
30 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABBV-3373 and Adalimumab in people with Rheumatoid Arthritis (RA), run by AbbVie at 30 sites in 7 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 3 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 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Hungary, Israel, Poland, Puerto Rico and 2 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?
Yes. Results are posted in the registry (first posted 19 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline to Week 12 in Disease Activity Score (DAS) 28 (C-reactive Protein [CRP]) (time frame: Baseline and Week 12). 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 NCT03823391, which also lists 1 linked publication.
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 19 Jul 2021.