Rheumatoid ArthritisPhase 2NCT02387762
ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate
A Phase 2 study testing acalabrutinib in people with Rheumatoid Arthritis, run by Acerta Pharma BV at 17 sites in United States.
Trial summary
This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate. 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?
- acalabrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 17 sitesUnited States
- Study dates
- Apr 2015to Jun 2016
- 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
Main Inclusion Criteria:
- Diagnosis of RA according to the 2010 ACR/EULAR Classification Criteria .
- Must be on a stable MTX dose (7.5 to 25 mg/week)
- Subjects must be able to read and understand the consent form, complete the study-related procedures, and communicate with the study staff.
- Are willing and able to adhere to the study visit schedule, and understand and comply with other protocol requirements.
Main Exclusion Criteria:
- Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 5 years.
- A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ACP-196, or put the study outcomes at undue risk.
- Subjects who have taken any investigational drug within the previous 30 days before randomization.
- Use of all other synthetic disease-modifying antirheumatic drugs (DMARDS) such as but not limited to leflunomide, azathioprine, cyclosporine, penicillamine or gold salts within 8 weeks of randomization.
- Use of etanercept, anakinra, tofacitinib within 4 weeks of randomization.
- Use of abatacept, humira, infliximab, or tocilizumab within 8 weeks of randomization.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Pinnacle Research Group
Anniston, Alabama, 36207
Achieve Clinical Research
Birmingham, Alabama, 35216
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
TriWest Research Associates, LLC
El Cajon, California, 92020
San Marcus Research Clinic, Inc.
Hialeah, Florida, 33015
Office of George Timothy Kelly, MD
Las Vegas, Nevada, 89128
Ramesh C. Gupta, MD
Memphis, Tennessee, 38119
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652
Suncoast Clinical Research
New Port Richey, Florida, 34652
Health Research of Oklahoma
Oklahoma City, Oklahoma, 73103-2433
Neuropsychiatric Research Center of Orange County
Orange, California, 92868
The Arthritis Center
Palm Harbor, Florida, 34684-3176
PMG Research of Salisbury
Salisbury, North Carolina, 28144
Pacific Arthritis Center Medical Group
Santa Monica, California, 93454
Advanced Arthritis Care and Research
Scottsdale, Arizona, 85258
Inland Rheumatology and Osteoporosis Medical Group, Inc
Upland, California, 91786
Clear Lake Regional Medical Center
Webster, Texas, 77598
About this study
Official title: A Phase 2a, 4-Week, Double-Blind, Proof-of-Concept Efficacy and Safety Study of ACP-196 Versus Placebo in Subjects With Active Rheumatoid Arthritis on Background Methotrexate
This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate.
Read the detailed description
A multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. The on-treatment period is 4 weeks with weekly visits to the clinic, followed by a 4-week safety follow-up period after the last dose of ACP-196/placebo. The study was to evaluate the safety, PK, PD, and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate
- Conditions
- Rheumatoid Arthritis
- Being tested
- acalabrutinib, Placebo
- Keywords
- Acalabrutinib
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acalabrutinibDrug
Also called methotrexate
PlaceboDrug
Also called methotrexate
| Study group | Role | What they receive |
|---|---|---|
| ACP-196 + Methotrexate | Experimental | Oral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week Receives: Drug: acalabrutinib |
| Placebo + Methotrexate | Placebo comparator | Oral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Activity Score 28-CRP (DAS28-CRP) at Week 4
Disease activity score 28 - C-reactive protein (DAS28-CRP) is a score to measure disease activity in patients with rheumatoid arthritis by aggregating data of 28 joints, and is calculated by the scores on scale using the following variables: The number of swollen and tender joints, CRP level, and patient's global assessment of disease activity. The total score of the DAS28 values may range from 2.0 to 10.0 while higher values mean a higher disease activity.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2016
- Study completionJun 2016
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.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Acerta Pharma BVThe 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acerta Pharma BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Acerta Clinical Trials, Study director, Acerta Pharma, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387762
- Sponsor's protocol ID
- ACE-RA-001
- Status last verified
- Mar 2019
- First submitted
- 1 Mar 2015
- Last updated
- 2 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, 4-Week, Double-Blind, Proof-of-Concept Efficacy and Safety Study of ACP-196 Versus Placebo in Subjects With Active Rheumatoid Arthritis on Background Methotrexate
- ClinicalTrials.gov ID
- NCT02387762
- Acronym / sponsor ID
- ACE-RA-001
- Conditions
- Rheumatoid Arthritis
- Keywords
- Acalabrutinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Acerta Pharma BVIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 13 Mar 2015 (estimated)
- Results
- Posted 26 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate.
Detailed description
A multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. The on-treatment period is 4 weeks with weekly visits to the clinic, followed by a 4-week safety follow-up period after the last dose of ACP-196/placebo. The study was to evaluate the safety, PK, PD, and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate
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 |
|---|---|---|
| ACP-196 + Methotrexate | Experimental | Drug: acalabrutinibOral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week |
| Placebo + Methotrexate | Placebo comparator | Drug: PlaceboOral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| acalabrutinibAlso: methotrexate | Drug | ACP-196 + Methotrexate |
| PlaceboAlso: methotrexate | Drug | Placebo + Methotrexate |
Primary outcome
Disease Activity Score 28-CRP (DAS28-CRP) at Week 4
Time frame: 4 weeks
Disease activity score 28 - C-reactive protein (DAS28-CRP) is a score to measure disease activity in patients with rheumatoid arthritis by aggregating data of 28 joints, and is calculated by the scores on scale using the following variables: The number of swollen and tender joints, CRP level, and patient's global assessment of disease activity. The total score of the DAS28 values may range from 2.0 to 10.0 while higher values mean a higher disease activity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Acerta Clinical Trials study director
Acerta Pharma, LLC
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing acalabrutinib in people with Rheumatoid Arthritis, run by Acerta Pharma BV at 17 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?
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 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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. 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 26 Mar 2019). 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?
Disease Activity Score 28-CRP (DAS28-CRP) at Week 4 (time frame: 4 weeks). 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 2 Apr 2019.