Rheumatoid ArthritisPhase 2NCT01960855

A Study Investigating the Efficacy and Safety of ABT-494 Given With Methotrexate in Subjects With Rheumatoid Arthritis Who Failed Anti-Tumor Necrosis Factor (TNF) Biologic Therapy

A Phase 2 study testing ABT-494 in people with Rheumatoid Arthritis, run by AbbVie.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective is to compare the safety and efficacy of multiple doses of ABT-494 versus placebo in moderately to severely active RA subjects on stable background MTX therapy with inadequate response or intolerance to anti-TNF biologic therapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: ABT-494
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 276 participants
Where: No sites listed yet
Study dates: Oct 2013to Jul 2015
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosed with rheumatoid arthritis (RA) based on either the 1987-revised American College of Rheumatology (ACR) classification criteria or the 2010 American College of Rheumatology/European League against Rheumatism (ACR/EULAR) criteria for ≥ 3 months.
Subjects must have been receiving oral or parenteral methotrexate (MTX) therapy ≥ 3 months and on a stable prescription of 7.5 to 25 mg/week for at least 4 weeks prior to initiating the study drug. Subjects should also be on a stable dose of folic acid (or equivalent) for at least 4 weeks prior to initiating the study drug. Subjects should continue with their stable doses of MTX and folic acid throughout the study
Subjects have been treated with 1 or more anti-tumor necrosis factor (TNF) biologics (no maximum cap) for ≥ 3 months but continue to exhibit active RA, or had to discontinue due to intolerability or toxicity. In addition, subjects with prior exposure to non-anti-TNF biologic(s) (no maximum cap) (e.g., abatacept, rituximab, anakinra, or tocilizumab) are allowed.
Have active RA as defined by the following minimum disease activity criteria: ≥ 6 swollen joints (based on 66 joint counts) at Screening and Baseline, ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline, high sensitivity C reactive protein (hs-CRP) > Upper Limit of Normal (ULN) OR positive for both rheumatoid factor and anti-cyclic citrullinated peptide (anti-CCP) antibody.

Who cannot join

Prior exposure to Janus Activated Kinase (JAK) inhibitor (e.g. tofacitinib, baricitinib)
Pregnant or breastfeeding female
Ongoing or active infection.

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 Given With Methotrexate (MTX) in Subjects With Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy

Conditions: Rheumatoid Arthritis
Being tested: ABT-494, Placebo
Keywords: anti-inflammatory agents, Joint Diseases, Arthritis, Musculoskeletal Disease, antirheumatic agents
Medical subject headings: Arthritis, Rheumatoid, Joint Diseases, Arthritis, Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABT-494Drug
ABT-494 capsule administered orally twice daily (BID).
PlaceboDrug
Placebo for ABT-494 capsule administered orally twice daily (BID).

Study groups in NCT01960855
Study group	Role	What they receive
Placebo BID	Placebo comparator	Placebo twice daily (BID) for 12 weeks. Receives: Drug: Placebo
ABT-494 3 mg BID	Experimental	ABT-494 3 mg twice daily (BID) for 12 weeks. Receives: Drug: ABT-494
ABT-494 6 mg BID	Experimental	ABT-494 6 mg twice daily (BID) for 12 weeks. Receives: Drug: ABT-494
ABT-494 12 mg BID	Experimental	ABT-494 12 mg twice daily (BID) for 12 weeks. Receives: Drug: ABT-494
ABT-494 18 mg BID	Experimental	ABT-494 18 mg twice daily (BID) for 12 weeks. Receives: Drug: ABT-494

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hs CRP). Last observation carried forward (LOCF) was used for missing data.
Measured: Baseline (Week 0) and Week 12

Secondary outcomes (4)

Number of Subjects Achieving American College of Rheumatology 50% (ACR50) Response at Week 12
Response defined as at least 50% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hs CRP. LOCF was used.
Measured: Baseline (Week 0) and Week 12
Number of Subjects Achieving American College of Rheumatology 70% (ACR70) Response at Week 12
Response defined as at least 70% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hs CRP. LOCF was used.
Measured: Baseline (Week 0) and Week 12
Number of Subjects Achieving Low Disease Activity (LDA) Based on Disease Activity Score (DAS28) or Clinical Remission (CR) Based on (DAS28) at Week 12
LDA is defined as DAS28 from 2.6 to < 3.2 at Week 12. CR is defined as DAS28 (CRP) < 2.6 at Week 12. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hs CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. LOCF was used.
Measured: Baseline (Week 0) and Week 12
Number of Subjects Achieving CR Based on DAS28 at Week 12
The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hs CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. LOCF was used.
Measured: Baseline (Week 0) and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Jul 2015

First posted11 Oct 2013 (estimated)
Study startOct 2013
Primary completionJul 2015
Study completionJul 2015

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 (5)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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 276 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01960855
Sponsor's protocol ID: M13-550
Other IDs: 2013-002358-57
Status last verified: Jul 2021
First submitted: 9 Oct 2013
Last updated: 24 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
Individual data sharing: Undecided

Publications

Kremer JM, Emery P, Camp HS, Friedman A, Wang L, Othman AA, Khan N, Pangan AL, Jungerwirth S, Keystone EC. A Phase IIb Study of ABT-494, a Selective JAK-1 Inhibitor, in Patients With Rheumatoid Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Therapy. Arthritis Rheumatol. 2016 Dec;68(12):2867-2877. doi: 10.1002/art.39801.
PubMed 27389975
Yamaoka K, Tanaka Y, Kameda H, Khan N, Sasaki N, Harigai M, Song Y, Zhang Y, Takeuchi T. The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan. Drug Saf. 2021 Jun;44(6):711-722. doi: 10.1007/s40264-021-01067-x. Epub 2021 May 27.
PubMed 34041702
Nader A, Mohamed MF, Winzenborg I, Doelger E, Noertersheuser P, Pangan AL, Othman AA. Exposure-Response Analyses of Upadacitinib Efficacy and Safety in Phase II and III Studies to Support Benefit-Risk Assessment in Rheumatoid Arthritis. Clin Pharmacol Ther. 2020 Apr;107(4):994-1003. doi: 10.1002/cpt.1671. Epub 2019 Nov 30.
PubMed 31610021
Mohamed MF, Klunder B, Camp HS, Othman AA. Exposure-Response Analyses of Upadacitinib Efficacy in Phase II Trials in Rheumatoid Arthritis and Basis for Phase III Dose Selection. Clin Pharmacol Ther. 2019 Dec;106(6):1319-1327. doi: 10.1002/cpt.1543. Epub 2019 Aug 23.
PubMed 31194885
Klunder B, Mohamed MF, Othman AA. Population Pharmacokinetics of Upadacitinib in Healthy Subjects and Subjects with Rheumatoid Arthritis: Analyses of Phase I and II Clinical Trials. Clin Pharmacokinet. 2018 Aug;57(8):977-988. doi: 10.1007/s40262-017-0605-6.
PubMed 29076110

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 Given With Methotrexate (MTX) in Subjects With Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy
ClinicalTrials.gov ID: NCT01960855
Acronym / sponsor ID: M13-550
Conditions: Rheumatoid Arthritis
Keywords: anti-inflammatory agents, Joint Diseases, Arthritis, Musculoskeletal Disease, antirheumatic agents
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 276 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: Oct 2013 (actual)
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 11 Oct 2013 (estimated)
Results: Posted 27 Jun 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Placebo BID	Placebo comparator	Drug: PlaceboPlacebo twice daily (BID) for 12 weeks.
ABT-494 3 mg BID	Experimental	Drug: ABT-494ABT-494 3 mg twice daily (BID) for 12 weeks.
ABT-494 6 mg BID	Experimental	Drug: ABT-494ABT-494 6 mg twice daily (BID) for 12 weeks.
ABT-494 12 mg BID	Experimental	Drug: ABT-494ABT-494 12 mg twice daily (BID) for 12 weeks.
ABT-494 18 mg BID	Experimental	Drug: ABT-494ABT-494 18 mg twice daily (BID) for 12 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosed with rheumatoid arthritis (RA) based on either the 1987-revised American College of Rheumatology (ACR) classification criteria or the 2010 American College of Rheumatology/European League against Rheumatism (ACR/EULAR) criteria for ≥ 3 months.
Subjects must have been receiving oral or parenteral methotrexate (MTX) therapy ≥ 3 months and on a stable prescription of 7.5 to 25 mg/week for at least 4 weeks prior to initiating the study drug. Subjects should also be on a stable dose of folic acid (or equivalent) for at least 4 weeks prior to initiating the study drug. Subjects should continue with their stable doses of MTX and folic acid throughout the study
Subjects have been treated with 1 or more anti-tumor necrosis factor (TNF) biologics (no maximum cap) for ≥ 3 months but continue to exhibit active RA, or had to discontinue due to intolerability or toxicity. In addition, subjects with prior exposure to non-anti-TNF biologic(s) (no maximum cap) (e.g., abatacept, rituximab, anakinra, or tocilizumab) are allowed.
Have active RA as defined by the following minimum disease activity criteria: ≥ 6 swollen joints (based on 66 joint counts) at Screening and Baseline, ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline, high sensitivity C reactive protein (hs-CRP) > Upper Limit of Normal (ULN) OR positive for both rheumatoid factor and anti-cyclic citrullinated peptide (anti-CCP) antibody.

Key exclusion criteria (3 listed)

Prior exposure to Janus Activated Kinase (JAK) inhibitor (e.g. tofacitinib, baricitinib)
Pregnant or breastfeeding female
Ongoing or active infection.

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-494ABT-494 capsule administered orally twice daily (BID).	Drug	ABT-494 12 mg BID, ABT-494 18 mg BID, ABT-494 3 mg BID, ABT-494 6 mg BID
PlaceboPlacebo for ABT-494 capsule administered orally twice daily (BID).	Drug	Placebo BID

Primary outcome

Number of Subjects Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Time frame: Baseline (Week 0) and Week 12
Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hs CRP). Last observation carried forward (LOCF) was used for missing data.

4 secondary outcomes

Number of Subjects Achieving American College of Rheumatology 50% (ACR50) Response at Week 12
Time frame: Baseline (Week 0) and Week 12
Number of Subjects Achieving American College of Rheumatology 70% (ACR70) Response at Week 12
Time frame: Baseline (Week 0) and Week 12
Number of Subjects Achieving Low Disease Activity (LDA) Based on Disease Activity Score (DAS28) or Clinical Remission (CR) Based on (DAS28) at Week 12
Time frame: Baseline (Week 0) and Week 12
Number of Subjects Achieving CR Based on DAS28 at Week 12
Time frame: Baseline (Week 0) and Week 12

Results and safety

Results posted to the registry on 27 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo BID	56	45
ABT-494 3 mg BID	55	51
ABT-494 6 mg BID	55	46
ABT-494 12 mg BID	55	51
ABT-494 18 mg BID	55	50

Primary outcome: Number of Subjects Achieving American College of Rheumatology 20% (ACR20) Response at Week 12

Time frame: Baseline (Week 0) and Week 12. Count of participants. Unit: Participants

Measure	Placebo BID n = 54	ABT-494 3 mg BID n = 54	ABT-494 6 mg BID n = 52	ABT-494 12 mg BID n = 55	ABT-494 18 mg BID n = 55
Value	19	30	33	40	39

Placebo BID vs ABT-494 3 mg BID: p = 0.033, Chi-squared
Placebo BID vs ABT-494 6 mg BID: p = 0.004, Chi-squared
Placebo BID vs ABT-494 12 mg BID: p < 0.001, Chi-squared

Population analysed: Subjects in the modified intent-to-treat (mITT) population with a baseline value and at least 1 post-baseline value

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until up to 30 days after discontinuation of study drug (up to 16 weeks); SAEs were collected from the time informed consent was obtained (20 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo BID	1 of 56 (1.8%)	9 of 56 (16.1%)	0 of 56
ABT-494 3 mg BID	2 of 55 (3.6%)	13 of 55 (23.6%)	0 of 55
ABT-494 6 mg BID	2 of 55 (3.6%)	9 of 55 (16.4%)	0 of 55
ABT-494 12 mg BID	0 of 55 (0%)	14 of 55 (25.5%)	0 of 55
ABT-494 18 mg BID	1 of 55 (1.8%)	27 of 55 (49.1%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27389975Kremer JM, Emery P, Camp HS, Friedman A, Wang L, Othman AA, Khan N, Pangan AL, Jungerwirth S, Keystone EC. A Phase IIb Study of ABT-494, a Selective JAK-1 Inhibitor, in Patients With Rheumatoid Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Therapy. Arthritis Rheumatol. 2016 Dec;68(12):2867-2877. doi: 10.1002/art.39801.
Derived from this study: PubMed 34041702Yamaoka K, Tanaka Y, Kameda H, Khan N, Sasaki N, Harigai M, Song Y, Zhang Y, Takeuchi T. The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan. Drug Saf. 2021 Jun;44(6):711-722. doi: 10.1007/s40264-021-01067-x. Epub 2021 May 27.
Derived from this study: PubMed 31610021Nader A, Mohamed MF, Winzenborg I, Doelger E, Noertersheuser P, Pangan AL, Othman AA. Exposure-Response Analyses of Upadacitinib Efficacy and Safety in Phase II and III Studies to Support Benefit-Risk Assessment in Rheumatoid Arthritis. Clin Pharmacol Ther. 2020 Apr;107(4):994-1003. doi: 10.1002/cpt.1671. Epub 2019 Nov 30.
Derived from this study: PubMed 31194885Mohamed MF, Klunder B, Camp HS, Othman AA. Exposure-Response Analyses of Upadacitinib Efficacy in Phase II Trials in Rheumatoid Arthritis and Basis for Phase III Dose Selection. Clin Pharmacol Ther. 2019 Dec;106(6):1319-1327. doi: 10.1002/cpt.1543. Epub 2019 Aug 23.
Derived from this study: PubMed 29076110Klunder B, Mohamed MF, Othman AA. Population Pharmacokinetics of Upadacitinib in Healthy Subjects and Subjects with Rheumatoid Arthritis: Analyses of Phase I and II Clinical Trials. Clin Pharmacokinet. 2018 Aug;57(8):977-988. doi: 10.1007/s40262-017-0605-6.
Individual participant dataSharing planned: Undecided

Related trials for Rheumatoid Arthritis

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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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-494 in people with Rheumatoid Arthritis, run by AbbVie.

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 4 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 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 27 Jun 2018). 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?

Number of Subjects Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 (time frame: Baseline (Week 0) 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 NCT01960855, which also lists 5 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 24 Aug 2021.