Rheumatoid ArthritisPhase 3NCT03414502
Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response
A Phase 3 study testing Methotrexate, Abatacept and Adalimumab in people with Rheumatoid Arthritis, run by University of Nebraska at 1 site in United States.
Trial summary
Rheumatoid arthritis (RA) is a common disease with approximately 1% prevalence. RA is also a chronic, progressive disease with no cure. Current treatment goals are to minimize pain, limit joint damage, and prevent loss of function. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Methotrexate, Abatacept and Adalimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2007to Mar 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed rheumatoid arthritis (RA) with 4 of 7 American College of Rheumatology criteria
- Morning stiffness for at least 1 hour for at least 6 weeks
- Swelling of 3 or more joints for at least 6 weeks
- Swelling of wrist, metacarpophalangeal (MCP), or proximal interphalangeal joints for 6 or more weeks
- Symmetric joint swelling
- Hand x-rays with erosions or bony decalcifications
Show all 19Show fewer
- RA nodules
- Rheumatoid factor (RF) positive
- >19 yrs old at RA diagnosis
- Active disease with at least 1 swollen joint
- Starting new DMARD medication(s) (abatacept, adalimumab, azathioprine, barcitinib, certolizumab, etanercept, golimumab, hydroxychloroquine, infliximab, leflunomide, methotrexate, minocycline, rituximab, sarilumab, sulfasalazine, tofacitinib)
- If on other DMARDS, must be on stable dose for ≥ 6 wks
- If on glucocorticoids, must be on stable dose for 2 wks (< 10mg of Prednisone/day or equivalent)
- Able to adhere to study visit schedule: enrollment (8 wks \& 16 wks +/- 2 wks)
- Hemoglobin (Hgb) > 9g/dl
- Platelets >100
- Creatinine <1.6
- Aspartate transferase (AST) or alanine aminotransferase (ALT) at or below 1.2 x upper limit
- Albumin up to 1.0 g/dL below lower limit of normal
Who cannot join
- Pregnant or breastfeeding women
- Men and women of child bearing potential unwilling to practice effective method of contraception
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Aimee B Schreiner, MS, 402-559-7288, aischreiner@unmc.edu
Bridget E Kramer, RN, 402-559-7288, bridget.kramer@unmc.edu
About this study
Official title: Treatment of Rheumatoid Arthritis With Disease-modifying Antirheumatic Drugs (DMARDs): Predictors of Response
Rheumatoid arthritis (RA) is a common disease with approximately 1% prevalence. RA is also a chronic, progressive disease with no cure. Current treatment goals are to minimize pain, limit joint damage, and prevent loss of function. Drugs used to treat RA include non-steroidal anti-inflammatory drugs (NSAIDS), glucocorticoids, and disease-modifying anti-rheumatic drugs (DMARDs), including biologics. Methotrexate (MTX) is the DMARD of choice in the treatment of RA, because it has been shown to be both well-tolerated and effective in achieving clinical response and slowing radiographic progression of disease. However, this drug alone results in remissions in only a small subset of patients and reliable predictors of DMARD response have yet to be identified.
This study is open-label of 16-weeks duration to identify factors that help predict clinical responses to disease-modifying antirheumatic drugs (DMARD) therapies for rheumatoid arthritis (RA) participants. All participants will receive a starting dose of DMARD medication(s) which may be adjusted by the investigator as needed. If a participant becomes intolerant of a DMARD medication, the participant will be withdrawn at the discretion of the investigator. Necessary withdrawals prior to week 16 visits will be considered end of study. Otherwise, end of study data as well as study serum will be collected at week 16. A portion of the blood collected at baseline, week 8 and week 16 for the optional addendum portion of the study is for future research and will be utilized attempting to look to detect the generation of superoxide radicals. These radicals have been shown to be associated with inflammation and may correlate with the progression of RA, which if confirmed, should decrease the levels of these radicals signaling response to treatment.
Read the detailed description
Rheumatoid arthritis (RA) is a common disease with approximately 1% prevalence. RA is also a chronic, progressive disease with no cure. Current treatment goals are to minimize pain, limit joint damage, and prevent loss of function. Drugs used to treat RA include non-steroidal anti-inflammatory drugs (NSAIDS), glucocorticoids, and disease-modifying anti-rheumatic drugs (DMARDs), including biologics. Methotrexate (MTX) is the DMARD of choice in the treatment of RA, because it has been shown to be both well-tolerated and effective in achieving clinical response and slowing radiographic progression of disease. However, this drug alone results in remissions in only a small subset of patients and reliable predictors of DMARD response have yet to be identified.
Investigators have examined the discriminatory characteristics of several clinical and biologic parameters in predicting treatment response (at least 50% improvement based on American College of Rheumatology criteria), including rheumatoid factor (RF) isotypes (particularly Immunoglobulin A (IgA) and Immunoglobulin M (IgM), matrix metalloproteinase (MMP)-3, human leukocyte antigen-DR isotope (HLA-DRB1) shared epitope (SE)-containing alleles, C-reactive protein, and interleukin (IL)-1.
The purpose of the study is to prospectively gather information on participants with rheumatoid arthritis (RA) and their response to disease-modifying antirheumatic drugs (DMARD) therapy. Specifically, to evaluate the efficacy of DMARD therapy as defined by attaining American College of Rheumatology 50 (ACR50) response after 16 weeks of therapy and to identify predictors of DMARD response, such as genetic factors, serological factors or co-morbid conditions. A maximum of 400 rheumatoid arthritis (RA) participants will be enrolled in this 16-week, open-label study. Adult males and females will be enrolled, but RA is approximately three times more common in females.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Methotrexate, Abatacept, Adalimumab, Azathioprine, Baricitinib
- Keywords
- Methotrexate, DMARD
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Also called Methotrexate (MTX)
Starting dose of Methotrexate of 15 mg once a week plus folic acid 1mg daily.
AbataceptDrug
Also called Orencia
Starting dose may be adjusted as needed at investigator's discretion.
AdalimumabDrug
Also called Humira
Starting dose may be adjusted as needed at investigator's discretion.
AzathioprineDrug
Also called Imuran
Starting dose may be adjusted as needed at investigator's discretion.
BaricitinibDrug
Also called Olimuant
Starting dose may be adjusted as needed at investigator's discretion.
CertolizumabDrug
Also called Cimzia
Starting dose may be adjusted as needed at investigator's discretion.
EtanerceptDrug
Also called Enbrel
Starting dose may be adjusted as needed at investigator's discretion.
GolimumabDrug
Also called Simponi
Starting dose may be adjusted as needed at investigator's discretion.
Also called Plaquenil
Starting dose may be adjusted as needed at investigator's discretion.
InfliximabDrug
Also called Remicade
Starting dose may be adjusted as needed at investigator's discretion.
LeflunomideDrug
Also called Arava
Starting dose may be adjusted as needed at investigator's discretion.
MinocyclineDrug
Also called Minocin
Starting dose may be adjusted as needed at investigator's discretion.
RituximabDrug
Also called Rituxin
Starting dose may be adjusted as needed at investigator's discretion.
SarilumabDrug
Also called Kevzara
Starting dose may be adjusted as needed at investigator's discretion.
SulfasalazineDrug
Also called Azulfidine
Starting dose may be adjusted as needed at investigator's discretion.
TofacitinibDrug
Also called Xeljanz
Starting dose may be adjusted as needed at investigator's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate Therapy | Active comparator | Participants will receive methotrexate therapy for rheumatoid arthritis (RA) treatment. Receives: Drug: Methotrexate |
| Abatacept Therapy | Active comparator | Participants will receive abatacept therapy for rheumatoid arthritis (RA) treatment. Receives: Drug: Abatacept |
| Adalimumab Therapy | Active comparator | Participants will receive adalimumab therapy for rheumatoid arthritis (RA) treatment. Receives: Drug: Adalimumab |
| Azathioprine Therapy | Active comparator | Participants will receive azathioprine therapy for rheumatoid arthritis (RA) treatment. Receives: Drug: Azathioprine |
| Barcitinib Therapy | Active comparator | Participants will receive barcitinib therapy for rheumatoid arthritis (RA) treatment. Receives: Drug: Baricitinib |
| Certolizumab Therapy | Active comparator | Participants will receive certolizumab therapy for rheumatoid arthritis (RA) treatment. Receives: Drug: Certolizumab |
| Etanercept Therapy | Active comparator | Participants will receive etanercept therapy for rheumatoid arthritis (RA) treatment. Receives: Drug: Etanercept |
| Golimumab Therapy | Active comparator | Participants will receive golimumab therapy for rheumatoid arthritis (RA) treatment. Receives: Drug: Golimumab |
| Hydroxycholoroquine Therapy | Active comparator | Participants will receive hydroxychloroquine therapy for rheumatoid arthritis (RA) treatment. Receives: Drug: Hydroxychloroquine |
| Infliximab Therapy | Active comparator | Participants will receive infliximab therapy for rheumatoid arthritis (RA) treatment. Receives: Drug: Infliximab |
| Leflunomide Therapy | Active comparator | Participants will receive leflunomide therapy for rheumatoid arthritis (RA) treatment. Receives: Drug: Leflunomide |
| Minocycline Therapy | Active comparator | Participants will receive minocycline therapy for rheumatoid arthritis (RA) treatment. Receives: Drug: Minocycline |
| Rituximab Therapy | Active comparator | Participants will receive rituximab therapy for rheumatoid arthritis (RA) treatment. Receives: Drug: Rituximab |
| Sarilumab Therapy | Active comparator | Participants will receive sarilumab therapy for rheumatoid arthritis (RA) treatment. Receives: Drug: Sarilumab |
| Sulfasalazine Therapy | Active comparator | Participants will receive sulfasalazine therapy for rheumatoid arthritis (RA) treatment. Receives: Drug: Sulfasalazine |
| Tofacitinib Therapy | Active comparator | Participants will receive tofacitinib therapy for rheumatoid arthritis (RA) treatment. Receives: Drug: Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Disease-modifying Antirheumatic Drugs Therapy for Rheumatoid Arthritis
The efficacy of the disease-modifying antirheumatic drugs (DMARD) in the study will be determined using the American College of Rheumatology 50 (ACR50). This is a composite measure defined as both improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Measured: 16 weeks
Secondary outcomes (3)
Genetic factors as Predictors of Disease-modifying Antirheumatic Drugs Response
Based on American College of Rheumatology 50 (ACR50) composite measure after 16 weeks of treatment, the number of participants will be determined that have genetic factors, such as the shared epitope, that demonstrate a 50% improvement in the number of tender and swollen joints, and a 50% improvement in three of five criteria: patient global assessment, physician global assessment, functional ability measure (most often Health Assessment Questionnaire/HAQ), visual analog pain scale and erythrocyte sedimentation rate or C-reactive protein (CRP).
Measured: 16 weeks
Serological Factors as Predictors of Disease-modifying Antirheumatic Drugs Response
Based on American College of Rheumatology 50 (ACR50) composite measure after 16 weeks of treatment, the number of participants will be determined that have serological factors, such as cyclic citrullinated peptide (CCP) isotypes, that demonstrate a 50% improvement in the number of tender and swollen joints, and a 50% improvement in three of five criteria: patient global assessment, physician global assessment, functional ability measure (most often Health Assessment Questionnaire/HAQ), visual analog pain scale and erythrocyte sedimentation rate or C-reactive protein (CRP).
Measured: 16 weeks
Co-morbid Conditions as Predictors of Disease-modifying Antirheumatic Drugs Response
Based on American College of Rheumatology 50 (ACR50) composite measure after 16 weeks of treatment, the number of participants will be determined that have co-morbid conditions, such as periodontal disease, that demonstrate a 50% improvement in the number of tender and swollen joints, and a 50% improvement in three of five criteria: patient global assessment, physician global assessment, functional ability measure (most often Health Assessment Questionnaire/HAQ), visual analog pain scale and erythrocyte sedimentation rate or C-reactive protein (CRP).
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start10 Dec 2007
- Primary completionMar 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James R O'Dell, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414502
- Sponsor's protocol ID
- 0439-23-FB
- Status last verified
- Jun 2026
- First submitted
- 2 Jan 2014
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Rheumatoid Arthritis With Disease-modifying Antirheumatic Drugs (DMARDs): Predictors of Response
- ClinicalTrials.gov ID
- NCT03414502
- Acronym / sponsor ID
- 0439-23-FB
- Conditions
- Rheumatoid Arthritis
- Keywords
- Methotrexate, DMARD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 10 Dec 2007 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 30 Jan 2018 (actual)
- 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.
Rheumatoid arthritis (RA) is a common disease with approximately 1% prevalence. RA is also a chronic, progressive disease with no cure. Current treatment goals are to minimize pain, limit joint damage, and prevent loss of function. Drugs used to treat RA include non-steroidal anti-inflammatory drugs (NSAIDS), glucocorticoids, and disease-modifying anti-rheumatic drugs (DMARDs), including biologics. Methotrexate (MTX) is the DMARD of choice in the treatment of RA, because it has been shown to be both well-tolerated and effective in achieving clinical response and slowing radiographic progression of disease. However, this drug alone results in remissions in only a small subset of patients and reliable predictors of DMARD response have yet to be identified.
This study is open-label of 16-weeks duration to identify factors that help predict clinical responses to disease-modifying antirheumatic drugs (DMARD) therapies for rheumatoid arthritis (RA) participants. All participants will receive a starting dose of DMARD medication(s) which may be adjusted by the investigator as needed. If a participant becomes intolerant of a DMARD medication, the participant will be withdrawn at the discretion of the investigator. Necessary withdrawals prior to week 16 visits will be considered end of study. Otherwise, end of study data as well as study serum will be collected at week 16. A portion of the blood collected at baseline, week 8 and week 16 for the optional addendum portion of the study is for future research and will be utilized attempting to look to detect the generation of superoxide radicals. These radicals have been shown to be associated with inflammation and may correlate with the progression of RA, which if confirmed, should decrease the levels of these radicals signaling response to treatment.
Detailed description
Rheumatoid arthritis (RA) is a common disease with approximately 1% prevalence. RA is also a chronic, progressive disease with no cure. Current treatment goals are to minimize pain, limit joint damage, and prevent loss of function. Drugs used to treat RA include non-steroidal anti-inflammatory drugs (NSAIDS), glucocorticoids, and disease-modifying anti-rheumatic drugs (DMARDs), including biologics. Methotrexate (MTX) is the DMARD of choice in the treatment of RA, because it has been shown to be both well-tolerated and effective in achieving clinical response and slowing radiographic progression of disease. However, this drug alone results in remissions in only a small subset of patients and reliable predictors of DMARD response have yet to be identified.
Investigators have examined the discriminatory characteristics of several clinical and biologic parameters in predicting treatment response (at least 50% improvement based on American College of Rheumatology criteria), including rheumatoid factor (RF) isotypes (particularly Immunoglobulin A (IgA) and Immunoglobulin M (IgM), matrix metalloproteinase (MMP)-3, human leukocyte antigen-DR isotope (HLA-DRB1) shared epitope (SE)-containing alleles, C-reactive protein, and interleukin (IL)-1.
The purpose of the study is to prospectively gather information on participants with rheumatoid arthritis (RA) and their response to disease-modifying antirheumatic drugs (DMARD) therapy. Specifically, to evaluate the efficacy of DMARD therapy as defined by attaining American College of Rheumatology 50 (ACR50) response after 16 weeks of therapy and to identify predictors of DMARD response, such as genetic factors, serological factors or co-morbid conditions. A maximum of 400 rheumatoid arthritis (RA) participants will be enrolled in this 16-week, open-label study. Adult males and females will be enrolled, but RA is approximately three times more common in females.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Methotrexate Therapy | Active comparator | Drug: MethotrexateParticipants will receive methotrexate therapy for rheumatoid arthritis (RA) treatment. |
| Abatacept Therapy | Active comparator | Drug: AbataceptParticipants will receive abatacept therapy for rheumatoid arthritis (RA) treatment. |
| Adalimumab Therapy | Active comparator | Drug: AdalimumabParticipants will receive adalimumab therapy for rheumatoid arthritis (RA) treatment. |
| Azathioprine Therapy | Active comparator | Drug: AzathioprineParticipants will receive azathioprine therapy for rheumatoid arthritis (RA) treatment. |
| Barcitinib Therapy | Active comparator | Drug: BaricitinibParticipants will receive barcitinib therapy for rheumatoid arthritis (RA) treatment. |
| Certolizumab Therapy | Active comparator | Drug: CertolizumabParticipants will receive certolizumab therapy for rheumatoid arthritis (RA) treatment. |
| Etanercept Therapy | Active comparator | Drug: EtanerceptParticipants will receive etanercept therapy for rheumatoid arthritis (RA) treatment. |
| Golimumab Therapy | Active comparator | Drug: GolimumabParticipants will receive golimumab therapy for rheumatoid arthritis (RA) treatment. |
| Hydroxycholoroquine Therapy | Active comparator | Drug: HydroxychloroquineParticipants will receive hydroxychloroquine therapy for rheumatoid arthritis (RA) treatment. |
| Infliximab Therapy | Active comparator | Drug: InfliximabParticipants will receive infliximab therapy for rheumatoid arthritis (RA) treatment. |
| Leflunomide Therapy | Active comparator | Drug: LeflunomideParticipants will receive leflunomide therapy for rheumatoid arthritis (RA) treatment. |
| Minocycline Therapy | Active comparator | Drug: MinocyclineParticipants will receive minocycline therapy for rheumatoid arthritis (RA) treatment. |
| Rituximab Therapy | Active comparator | Drug: RituximabParticipants will receive rituximab therapy for rheumatoid arthritis (RA) treatment. |
| Sarilumab Therapy | Active comparator | Drug: SarilumabParticipants will receive sarilumab therapy for rheumatoid arthritis (RA) treatment. |
| Sulfasalazine Therapy | Active comparator | Drug: SulfasalazineParticipants will receive sulfasalazine therapy for rheumatoid arthritis (RA) treatment. |
| Tofacitinib Therapy | Active comparator | Drug: TofacitinibParticipants will receive tofacitinib therapy for rheumatoid arthritis (RA) treatment. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Diagnosed rheumatoid arthritis (RA) with 4 of 7 American College of Rheumatology criteria
- >19 yrs old at RA diagnosis
- Active disease with at least 1 swollen joint
- Starting new DMARD medication(s) (abatacept, adalimumab, azathioprine, barcitinib, certolizumab, etanercept, golimumab, hydroxychloroquine, infliximab, leflunomide, methotrexate, minocycline, rituximab, sarilumab, sulfasalazine, tofacitinib)
- If on other DMARDS, must be on stable dose for ≥ 6 wks
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding women
- Men and women of child bearing potential unwilling to practice effective method of contraception
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 |
|---|---|---|
| MethotrexateAlso: Methotrexate (MTX)Starting dose of Methotrexate of 15 mg once a week plus folic acid 1mg daily. | Drug | Methotrexate Therapy |
| AbataceptAlso: OrenciaStarting dose may be adjusted as needed at investigator's discretion. | Drug | Abatacept Therapy |
| AdalimumabAlso: HumiraStarting dose may be adjusted as needed at investigator's discretion. | Drug | Adalimumab Therapy |
| AzathioprineAlso: ImuranStarting dose may be adjusted as needed at investigator's discretion. | Drug | Azathioprine Therapy |
| BaricitinibAlso: OlimuantStarting dose may be adjusted as needed at investigator's discretion. | Drug | Barcitinib Therapy |
| CertolizumabAlso: CimziaStarting dose may be adjusted as needed at investigator's discretion. | Drug | Certolizumab Therapy |
| EtanerceptAlso: EnbrelStarting dose may be adjusted as needed at investigator's discretion. | Drug | Etanercept Therapy |
| GolimumabAlso: SimponiStarting dose may be adjusted as needed at investigator's discretion. | Drug | Golimumab Therapy |
| HydroxychloroquineAlso: PlaquenilStarting dose may be adjusted as needed at investigator's discretion. | Drug | Hydroxycholoroquine Therapy |
| InfliximabAlso: RemicadeStarting dose may be adjusted as needed at investigator's discretion. | Drug | Infliximab Therapy |
| LeflunomideAlso: AravaStarting dose may be adjusted as needed at investigator's discretion. | Drug | Leflunomide Therapy |
| MinocyclineAlso: MinocinStarting dose may be adjusted as needed at investigator's discretion. | Drug | Minocycline Therapy |
| RituximabAlso: RituxinStarting dose may be adjusted as needed at investigator's discretion. | Drug | Rituximab Therapy |
| SarilumabAlso: KevzaraStarting dose may be adjusted as needed at investigator's discretion. | Drug | Sarilumab Therapy |
| SulfasalazineAlso: AzulfidineStarting dose may be adjusted as needed at investigator's discretion. | Drug | Sulfasalazine Therapy |
| TofacitinibAlso: XeljanzStarting dose may be adjusted as needed at investigator's discretion. | Drug | Tofacitinib Therapy |
Primary outcome
Efficacy of Disease-modifying Antirheumatic Drugs Therapy for Rheumatoid Arthritis
Time frame: 16 weeks
The efficacy of the disease-modifying antirheumatic drugs (DMARD) in the study will be determined using the American College of Rheumatology 50 (ACR50). This is a composite measure defined as both improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
3 secondary outcomes
Genetic factors as Predictors of Disease-modifying Antirheumatic Drugs Response
Time frame: 16 weeks
Serological Factors as Predictors of Disease-modifying Antirheumatic Drugs Response
Time frame: 16 weeks
Co-morbid Conditions as Predictors of Disease-modifying Antirheumatic Drugs Response
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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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.
James R O'Dell, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methotrexate, Abatacept and Adalimumab in people with Rheumatoid Arthritis, run by University of Nebraska at 1 site 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 19 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: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aimee B Schreiner, MS (402-559-4873, aischreiner@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Disease-modifying Antirheumatic Drugs Therapy for Rheumatoid Arthritis (time frame: 16 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 17 Jun 2026.