Arthritis, RheumatoidMAPPIT-RANCT02720874
Multidisciplinary Approach for Treat To Target In Rheumatoid Arthritis
A study testing Rheumatoid arthritis educational booklet, Multidisciplinary rheumatologic care and Nurse education and monthly calls in people with Arthritis, Rheumatoid, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
Trial summary
This research will evaluate a multifaceted patient-centered intervention in a sample of socioeconomically disadvantaged Hispanic adults with rheumatoid arthritis (RA) that capitalizes on a partnership between the extended rheumatology healthcare team and each patient in order to promote understanding, uptake and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Rheumatoid arthritis educational booklet, Multidisciplinary rheumatologic care and Nurse education and monthly calls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 14 Apr 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Reside in Greater Los Angeles area and receive rheumatologic care at the adult rheumatology clinic at Harbor-UCLA Medical Center in Torrance, California
- Fulfill the 2010 American College of Rheumatology revised diagnostic criteria for RA
- Have at least moderate disease activity as indicated by a Clinical Disease Activity Index (CDAI) score >10 and Routine Assessment Patient Index Data (RAPID3) score >2
- Be able and willing to provide written informed consent and to adhere to the study visit schedule and other protocol
- Availability of a touch-tone landline or mobile telephone
- Of self-identified Hispanic/Latino descent
Who cannot join
- Known irreversible articular damage, including subluxations, arthrodesis, fusion, or prosthesis
- Functional class IV as defined by the American College of Rheumatology Classification of Functional Status in rheumatoid arthritis
- Overlapping autoimmune or mixed connective tissue syndromes
- Serious medical conditions, including: chronic infection, advanced or decompensated heart failure, higher than class II chronic kidney disease, cancer (unless in remission for period of 5 years or more), or any uncontrolled medical condition that is deemed by the investigators to interfere with the study protocol
- At risk for suicide
Trial locations and contacts
1 site in 1 country.
United States1 site
The Lundquist Institute at Harbor-UCLA Medical Center
Torrance, California, 90502
About this study
Official title: Multidisciplinary Approach to Patient-Physician Partnership In Treating To Target In Rheumatoid Arthritis
This research will evaluate a multifaceted patient-centered intervention in a sample of socioeconomically disadvantaged Hispanic adults with rheumatoid arthritis (RA) that capitalizes on a partnership between the extended rheumatology healthcare team and each patient in order to promote understanding, uptake and adherence to the principles of treat-to-target strategy. The primary hypothesis of this study is that the addition of a multifaceted intervention incorporating integrated multidisciplinary rheumatologic care, nurse-directed self-management education and supportive follow-up, and technology-based at home RA symptom monitoring and reporting to clinical guideline-based care will increase RA remission rate at 6 months.
Read the detailed description
One hundred and fifty Hispanic RA patients will be recruited for this proposal and randomized 1:1 to Intervention and Control arms for a period of 12 months. Participants will be recruited from the Adult Rheumatology clinic at Harbor-UCLA. Patients who meet enrollment criteria based on review of electronic medical records will be provided information about the study during regular outpatient visits. Interested patients will be formally screened.
After providing informed consent, eligible patients will complete baseline measures and be randomly assigned into Intervention and Control arms using a minimization protocol, with a goal of enrolling 150 patients (75 in each group). All participants will attend rheumatology clinic appointments scheduled quarterly for the 12-month trial duration, during which they will also complete assessments (at 3, 6, 9, and 12 months post-baseline; see description of outcomes for full detail). Between appointments with their assigned rheumatologist, participants will regularly self-monitor their RA symptoms using the Routine Assessment Patient Index Data (RAPID3) questionnaire administered via an interactive voice response (IVR) phone survey weekly for 12 months.
At baseline, participants will be enrolled in the IVR system and the study coordinator will provide a detailed orientation to the automated phone survey as well as written instructions including the toll-free phone number, and a unique study personal identification number. Participants will each select the day and the hours between which they will complete the weekly phone survey. After entering their unique study personal identification number, participants will complete the 12-item RAPID3 questionnaire, entering responses using their telephone keypad. If they do not call in and complete the survey on their preselected day during the specified time frame, they will receive a reminder call an hour later from the time by which they would have been expected to call in.
At the baseline visit, all participants will receive a rheumatoid arthritis educational booklet that provides general disease state information, including an overview of RA (e.g., its causes, associated symptoms, how it is diagnosed), RA medications and other treatment options, pain management, physical activity, nutrition and diet. The material is written at a sixth grade reading level and incorporates simple figures and graphics to enhance readability and promote participant comprehension and engagement. The study coordinator will also give each participant a pedometer and provide instruction for its use. Participants will be encouraged to wear the pedometer during waking hours and record their total daily steps in a log, along with the type and duration of other activities like swimming that pedometers do not capture.
Control arm participants will receive standard of care treatment from their assigned rheumatologists. Pharmacotherapy will be monitored and adjusted by the treating rheumatologist in accordance with evidence-based clinical practice guidelines. Physical Therapy referrals and evaluations will occur as indicated for addressing specific problems. Referral for psychological services will be provided when patients endorse symptoms of depression in response to a verbal screen or participant-initiated discussion. Control arm participants will also have regularly scheduled 20-30 minute monthly phone calls with the healthcare coordinator. While questions and concerns specifically raised by participants regarding study procedure and the content of the educational booklet will be addressed, these phone calls are primarily designed to control for potential benefit participants may derive from time on the phone with a health professional. The healthcare coordinator will engage participants using a non-directive approach based on use of active listening, reflective statements and similar techniques.
Intervention arm participants will receive integrated treatment from a multidisciplinary healthcare team during the routine clinic visits. In addition to appointments with their assigned rheumatologist, a physical therapist will assess participants' physical functioning, provide joint protection guidance and assist patients in making physical fitness plans based on their own goals and tailored to patients' abilities and physical limitations. Interim individual physical therapy sessions will be scheduled in accordance with the physical therapist's recommendations. Additionally, if during any routine clinic appointment a participant scores 10 or higher on the PHQ-9 and/or endorses symptoms of depression in response to a verbal screen, they will receive a same-day, in-clinic psychological evaluation. The psychologist will assess whether patient symptoms meet diagnostic criteria for a depressive disorder and, when clinically indicated, provide recommendations for treatment. Follow-up treatment appointments will be scheduled with patients by the psychologist.
In addition to regularly scheduled rheumatology appointments, if between-visit patient self-monitoring reports indicate an increase in RA disease activity (flare), participants in the intervention arm will be scheduled for an ad hoc evaluation with their assigned rheumatologist. Specifically, if participants' RAPID3 surveys show two consecutive week-to-week score increases and the cumulative two week RAPID3 increase is greater than 1.2 points, they will be contacted by the study coordinator that day (or following morning if surveys are completed after regular office hours) to schedule an ad-hoc appointment with their rheumatologist within 2 working days. During routine and ad hoc intervention arm patient visits, while clinical practice guidelines will inform rheumatologist monitoring of pharmacotherapy, the treatment planning process will be grounded in a shared decision making framework.
Participants in the intervention arm will further be provided a one-on-one tailored education session with a trained rheumatology nurse that will encompass a general disease state education, incorporating pictograms and short slide presentations, an introduction of the treat to target concept, overview of treatment options, and discussion of patient priorities and identification of personally salient long-term treatment-related goals. During regularly scheduled 20-30 minute monthly follow-up phone calls with each intervention arm participant, the rheumatology nurse will address individual educational needs, answer questions and reinforce learning. Goal setting, planning and review will also be conducted. Specifically, participants will select goals to be achieved in the upcoming month and be assisted in developing specific action plans. The rheumatology nurse will also check in about their work and progress on action plans discussed in the last phone call. Any barriers encountered will be explored and participants will be engaged in a problem-solving process, revising existing action plans as needed.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Rheumatoid arthritis educational booklet, Multidisciplinary rheumatologic care, Nurse education and monthly calls, Monthly healthcare coordinator calls, Technology-based symptom monitoring and reporting
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rheumatoid arthritis educational bookletBehavioural
Participants will receive a low-literacy rheumatoid arthritis educational booklet that provides general disease state information.
Multidisciplinary rheumatologic careBehavioural
At each regularly scheduled clinic appointment, participants will receive treatment from their assigned rheumatologist, undergo an in-clinic physical therapy evaluation and, if indicated, a psychological evaluation. Physical therapy and psychology follow-up sessions will occur as directed by the individual services.
Nurse education and monthly callsBehavioural
Participants will meet one-on-one with a rheumatology nurse for a tailored educational session encompassing disease state education, an introduction of the treat to target concept, an overview of treatment options, and goal setting and planning. During monthly follow-up calls, participant educational needs will be addressed; goal setting, planning and review will also be conducted.
Monthly healthcare coordinator callsBehavioural
During monthly calls with the healthcare coordinator, specific questions and concerns raised by participants may be addressed. The primary purpose of these calls is to control for potential benefit derived from time on the phone with a health professional.
Technology-based symptom monitoring and reportingBehavioural
When at home patient self-monitoring reports indicate a significant increase in RA disease activity, participants will be promptly contacted and scheduled for an ad hoc evaluation with their treating rheumatologist.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | In the multifaceted intervention, participants will first receive an educational session with monthly follow-up phone calls from a trained rheumatology nurse. A rheumatoid arthritis educational booklet will also be provided. During regularly scheduled clinic appointments (at baseline, 3 months, 6 months, 9 months, and 12 months), participants will receive multidisciplinary rheumatologic care, including evaluation by a rheumatologist, physical therapist and psychologist. In addition, participants will be scheduled for ad hoc rheumatology appointments if technology-based symptom monitoring and reporting indicates a marked increase in RA disease activity. Receives: Behavioral: Rheumatoid arthritis educational booklet; Behavioral: Multidisciplinary rheumatologic care; Behavioral: Nurse education and monthly calls; Behavioral: Technology-based symptom monitoring and reporting |
| Control Arm | Active comparator | Participants will receive standard of care treatment from their assigned rheumatologists during routine clinic appointments scheduled quarterly for the 12-month trial duration. Referrals to ancillary services will occur in a standard of care fashion. Participants will additionally receive monthly healthcare coordinator calls and be given the rheumatoid arthritis educational booklet. Receives: Behavioral: Rheumatoid arthritis educational booklet; Behavioral: Monthly healthcare coordinator calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants achieving remission based on the Clinical Disease Activity Index at 6 months
Remission as defined by a Clinical Disease Activity Index (CDAI) score ≤ 2.8. The CDAI is a pooled disease activity index based on the swollen joint count (0-28), tender joint count (0-28), patient global estimate (0-10), and physician global estimate (0-10); the CDAI scale ranges from 0-76, where higher scores represent higher disease activity.
Measured: 6 months
Percentage of participants achieving remission based on the Routine Assessment Patient Index Data at 6 months
Remission as defined by a Routine Assessment Patient Index Data (RAPID3) score ≤ 1. The RAPID3 is a self-report measure of disease activity and represents the average of patient ratings for physical function, pain and disease activity. Total RAPID3 scores range from 0 to 10, where higher scores represent higher patient-rated disease activity.
Measured: 6 months
Secondary outcomes (11)
Percentage of participants achieving remission based on the Clinical Disease Activity Index at 12 months
Remission as defined by a Clinical Disease Activity Index (CDAI) score ≤ 2.8.
Measured: 12 months
Percentage of participants achieving remission based on the Routine Assessment Patient Index Data at 12 months
Remission as defined by a Routine Assessment Patient Index Data (RAPID3) score ≤ 1.
Measured: 12 months
Percentage of participants with low disease activity based on the Clinical Disease Activity Index
Low disease activity defined by a Clinical Disease Activity Index (CDAI) score of 2.81-10.
Measured: 6 months, 12 months
Percentage of participants with low disease activity based on the Routine Assessment Patient Index Data
Low disease activity defined by a Routine Assessment Patient Index Data (RAPID3) score of 1.01-2.
Measured: 6 months, 12 months
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) from baseline
The HAQ-DI consists of 20 questions measuring patients' self-reported ability to perform activities of daily living in eight functional domains - dressing, arising, eating, walking, hygiene, reach, grip, and usual activities. Scores in each domain range from 0 (no disability) to 3 (completely disabled) and are averaged to calculate the HAQ-DI total score. Higher scores represent higher levels of disability, and negative change scores (visit minus baseline) indicate improvement.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Change in Patient Health Questionnaire (PHQ-9) depression from baseline
The PHQ-9 consists of nine items that parallel the diagnostic criteria for major depression in the fourth and fifth editions of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV and DSM-5). Items measure symptoms that have occurred over the past two weeks and are rated on a 4-point scale ranging from 0 (absence of symptoms) to 3 (presence of symptoms nearly every day). Negative change scores (visit minus baseline) indicate improvement.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Change in Patient Global Assessment of disease activity (PGA) from baseline
PGA of disease activity is measured using a 10 cm horizontal line visual analog scale. Higher scores represent higher patient-rated rheumatoid arthritis disease activity, and negative change scores (visit minus baseline) indicate improvement.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Change in Pain Visual Analogue Scale (VAS) from baseline
The pain VAS asks patients to rate the severity of their arthritis-related pain using a 10 cm horizontal line VAS ranging from no pain (0 cm) to unbearable pain (10 cm). Negative change scores (visit minus baseline) indicate improvement.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Change in Fatigue Visual Analogue Scale (VAS) from baseline
The fatigue VAS asks patients to rate the severity of their fatigue over the past week using a 10 cm horizontal line VAS ranging from no fatigue (0 cm) to extreme fatigue (10 cm). Negative change scores (visit minus baseline) indicate improvement.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Change in SF-36 health status from baseline
The 36-Item Short-Form Health Survey (SF-36) assesses general health status across eight domains: physical functioning, role limitations-physical, bodily pain, vitality, social functioning, role limitations-emotional, mental health, and general health. These domains can also be summarized as Physical Component Summary and Mental Component Summary scores. SF-36 domain and component summary scores are recalibrated to a 0-100 scale with higher scores indicating better health status; positive change scores (visit minus baseline) indicate improvement.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Change in Rheumatoid Arthritis Specific Work Productivity Survey (WPS-RA) from baseline
The WPS-RA is a nine-item questionnaire that assesses the impact of RA on work and household productivity, and participation in daily activities. Employed participants indicate number of work absences (absenteeism) and days with work productivity reduced ≥ 50% (presenteeism). All participants report number of days with no household work performed, days with household productivity reduced ≥ 50%, days that outside help was hired, and days with missed family, social or leisure activities. Participants also rate the extent to which RA interferes with their paid work (if applicable) and household productivity on a 0-10 scale ranging from no interference to complete interference. For all items, negative change scores (visit minus baseline) indicate improvement.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study start1 Jan 2025 (estimated)
- Primary completion14 Apr 2025
- Study completion14 Apr 2025
Why it stopped: Terminated due to several programmatic delays such as personnel transitions and departures, challenges to replace them as specified in the protocol, and delays due to COVID-19 pandemic-related institutional closures and clinical research pauses.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, George A Karpouzas, MD, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Investigators
- George A Karpouzas, MD, Principal investigator, The Lundquist Institute at Harbor-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720874
- Sponsor's protocol ID
- 21625-01
- Acronym
- MAPPIT-RA
- Status last verified
- Jul 2026
- First submitted
- 22 Mar 2016
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Approach to Patient-Physician Partnership In Treating To Target In Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02720874
- Acronym / sponsor ID
- MAPPIT-RA / 21625-01
- Conditions
- Arthritis, Rheumatoid
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated due to several programmatic delays such as personnel transitions and departures, challenges to replace them as specified in the protocol, and delays due to COVID-19 pandemic-related institutional closures and clinical research pauses.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 14 Apr 2025 (actual)
- Study completion
- 14 Apr 2025 (actual)
- First posted
- 28 Mar 2016 (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.
This research will evaluate a multifaceted patient-centered intervention in a sample of socioeconomically disadvantaged Hispanic adults with rheumatoid arthritis (RA) that capitalizes on a partnership between the extended rheumatology healthcare team and each patient in order to promote understanding, uptake and adherence to the principles of treat-to-target strategy. The primary hypothesis of this study is that the addition of a multifaceted intervention incorporating integrated multidisciplinary rheumatologic care, nurse-directed self-management education and supportive follow-up, and technology-based at home RA symptom monitoring and reporting to clinical guideline-based care will increase RA remission rate at 6 months.
Detailed description
One hundred and fifty Hispanic RA patients will be recruited for this proposal and randomized 1:1 to Intervention and Control arms for a period of 12 months. Participants will be recruited from the Adult Rheumatology clinic at Harbor-UCLA. Patients who meet enrollment criteria based on review of electronic medical records will be provided information about the study during regular outpatient visits. Interested patients will be formally screened.
After providing informed consent, eligible patients will complete baseline measures and be randomly assigned into Intervention and Control arms using a minimization protocol, with a goal of enrolling 150 patients (75 in each group). All participants will attend rheumatology clinic appointments scheduled quarterly for the 12-month trial duration, during which they will also complete assessments (at 3, 6, 9, and 12 months post-baseline; see description of outcomes for full detail). Between appointments with their assigned rheumatologist, participants will regularly self-monitor their RA symptoms using the Routine Assessment Patient Index Data (RAPID3) questionnaire administered via an interactive voice response (IVR) phone survey weekly for 12 months.
At baseline, participants will be enrolled in the IVR system and the study coordinator will provide a detailed orientation to the automated phone survey as well as written instructions including the toll-free phone number, and a unique study personal identification number. Participants will each select the day and the hours between which they will complete the weekly phone survey. After entering their unique study personal identification number, participants will complete the 12-item RAPID3 questionnaire, entering responses using their telephone keypad. If they do not call in and complete the survey on their preselected day during the specified time frame, they will receive a reminder call an hour later from the time by which they would have been expected to call in.
At the baseline visit, all participants will receive a rheumatoid arthritis educational booklet that provides general disease state information, including an overview of RA (e.g., its causes, associated symptoms, how it is diagnosed), RA medications and other treatment options, pain management, physical activity, nutrition and diet. The material is written at a sixth grade reading level and incorporates simple figures and graphics to enhance readability and promote participant comprehension and engagement. The study coordinator will also give each participant a pedometer and provide instruction for its use. Participants will be encouraged to wear the pedometer during waking hours and record their total daily steps in a log, along with the type and duration of other activities like swimming that pedometers do not capture.
Control arm participants will receive standard of care treatment from their assigned rheumatologists. Pharmacotherapy will be monitored and adjusted by the treating rheumatologist in accordance with evidence-based clinical practice guidelines. Physical Therapy referrals and evaluations will occur as indicated for addressing specific problems. Referral for psychological services will be provided when patients endorse symptoms of depression in response to a verbal screen or participant-initiated discussion. Control arm participants will also have regularly scheduled 20-30 minute monthly phone calls with the healthcare coordinator. While questions and concerns specifically raised by participants regarding study procedure and the content of the educational booklet will be addressed, these phone calls are primarily designed to control for potential benefit participants may derive from time on the phone with a health professional. The healthcare coordinator will engage participants using a non-directive approach based on use of active listening, reflective statements and similar techniques.
Intervention arm participants will receive integrated treatment from a multidisciplinary healthcare team during the routine clinic visits. In addition to appointments with their assigned rheumatologist, a physical therapist will assess participants' physical functioning, provide joint protection guidance and assist patients in making physical fitness plans based on their own goals and tailored to patients' abilities and physical limitations. Interim individual physical therapy sessions will be scheduled in accordance with the physical therapist's recommendations. Additionally, if during any routine clinic appointment a participant scores 10 or higher on the PHQ-9 and/or endorses symptoms of depression in response to a verbal screen, they will receive a same-day, in-clinic psychological evaluation. The psychologist will assess whether patient symptoms meet diagnostic criteria for a depressive disorder and, when clinically indicated, provide recommendations for treatment. Follow-up treatment appointments will be scheduled with patients by the psychologist.
In addition to regularly scheduled rheumatology appointments, if between-visit patient self-monitoring reports indicate an increase in RA disease activity (flare), participants in the intervention arm will be scheduled for an ad hoc evaluation with their assigned rheumatologist. Specifically, if participants' RAPID3 surveys show two consecutive week-to-week score increases and the cumulative two week RAPID3 increase is greater than 1.2 points, they will be contacted by the study coordinator that day (or following morning if surveys are completed after regular office hours) to schedule an ad-hoc appointment with their rheumatologist within 2 working days. During routine and ad hoc intervention arm patient visits, while clinical practice guidelines will inform rheumatologist monitoring of pharmacotherapy, the treatment planning process will be grounded in a shared decision making framework.
Participants in the intervention arm will further be provided a one-on-one tailored education session with a trained rheumatology nurse that will encompass a general disease state education, incorporating pictograms and short slide presentations, an introduction of the treat to target concept, overview of treatment options, and discussion of patient priorities and identification of personally salient long-term treatment-related goals. During regularly scheduled 20-30 minute monthly follow-up phone calls with each intervention arm participant, the rheumatology nurse will address individual educational needs, answer questions and reinforce learning. Goal setting, planning and review will also be conducted. Specifically, participants will select goals to be achieved in the upcoming month and be assisted in developing specific action plans. The rheumatology nurse will also check in about their work and progress on action plans discussed in the last phone call. Any barriers encountered will be explored and participants will be engaged in a problem-solving process, revising existing action plans as needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Rheumatoid arthritis educational booklet, Behavioral: Multidisciplinary rheumatologic care, Behavioral: Nurse education and monthly calls, Behavioral: Technology-based symptom monitoring and reportingIn the multifaceted intervention, participants will first receive an educational session with monthly follow-up phone calls from a trained rheumatology nurse. A rheumatoid arthritis educational booklet will also be provided. During regularly scheduled clinic appointments (at baseline, 3 months, 6 months, 9 months, and 12 months), participants will receive multidisciplinary rheumatologic care, including evaluation by a rheumatologist, physical therapist and psychologist. In addition, participants will be scheduled for ad hoc rheumatology appointments if technology-based symptom monitoring and reporting indicates a marked increase in RA disease activity. |
| Control Arm | Active comparator | Behavioral: Rheumatoid arthritis educational booklet, Behavioral: Monthly healthcare coordinator callsParticipants will receive standard of care treatment from their assigned rheumatologists during routine clinic appointments scheduled quarterly for the 12-month trial duration. Referrals to ancillary services will occur in a standard of care fashion. Participants will additionally receive monthly healthcare coordinator calls and be given the rheumatoid arthritis educational booklet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Reside in Greater Los Angeles area and receive rheumatologic care at the adult rheumatology clinic at Harbor-UCLA Medical Center in Torrance, California
- Fulfill the 2010 American College of Rheumatology revised diagnostic criteria for RA
- Have at least moderate disease activity as indicated by a Clinical Disease Activity Index (CDAI) score >10 and Routine Assessment Patient Index Data (RAPID3) score >2
- Be able and willing to provide written informed consent and to adhere to the study visit schedule and other protocol
- Availability of a touch-tone landline or mobile telephone
Key exclusion criteria (5 listed)
- Known irreversible articular damage, including subluxations, arthrodesis, fusion, or prosthesis
- Functional class IV as defined by the American College of Rheumatology Classification of Functional Status in rheumatoid arthritis
- Overlapping autoimmune or mixed connective tissue syndromes
- Serious medical conditions, including: chronic infection, advanced or decompensated heart failure, higher than class II chronic kidney disease, cancer (unless in remission for period of 5 years or more), or any uncontrolled medical condition that is deemed by the investigators to interfere with the study protocol
- At risk for suicide
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 |
|---|---|---|
| Rheumatoid arthritis educational bookletParticipants will receive a low-literacy rheumatoid arthritis educational booklet that provides general disease state information. | Behavioural | Control Arm, Intervention Arm |
| Multidisciplinary rheumatologic careAt each regularly scheduled clinic appointment, participants will receive treatment from their assigned rheumatologist, undergo an in-clinic physical therapy evaluation and, if indicated, a psychological evaluation. Physical therapy and psychology follow-up sessions will occur as directed by the individual services. | Behavioural | Intervention Arm |
| Nurse education and monthly callsParticipants will meet one-on-one with a rheumatology nurse for a tailored educational session encompassing disease state education, an introduction of the treat to target concept, an overview of treatment options, and goal setting and planning. During monthly follow-up calls, participant educational needs will be addressed; goal setting, planning and review will also be conducted. | Behavioural | Intervention Arm |
| Monthly healthcare coordinator callsDuring monthly calls with the healthcare coordinator, specific questions and concerns raised by participants may be addressed. The primary purpose of these calls is to control for potential benefit derived from time on the phone with a health professional. | Behavioural | Control Arm |
| Technology-based symptom monitoring and reportingWhen at home patient self-monitoring reports indicate a significant increase in RA disease activity, participants will be promptly contacted and scheduled for an ad hoc evaluation with their treating rheumatologist. | Behavioural | Intervention Arm |
Primary outcome
Percentage of participants achieving remission based on the Clinical Disease Activity Index at 6 months
Time frame: 6 months
Remission as defined by a Clinical Disease Activity Index (CDAI) score ≤ 2.8. The CDAI is a pooled disease activity index based on the swollen joint count (0-28), tender joint count (0-28), patient global estimate (0-10), and physician global estimate (0-10); the CDAI scale ranges from 0-76, where higher scores represent higher disease activity.
Percentage of participants achieving remission based on the Routine Assessment Patient Index Data at 6 months
Time frame: 6 months
Remission as defined by a Routine Assessment Patient Index Data (RAPID3) score ≤ 1. The RAPID3 is a self-report measure of disease activity and represents the average of patient ratings for physical function, pain and disease activity. Total RAPID3 scores range from 0 to 10, where higher scores represent higher patient-rated disease activity.
11 secondary outcomes
Percentage of participants achieving remission based on the Clinical Disease Activity Index at 12 months
Time frame: 12 months
Percentage of participants achieving remission based on the Routine Assessment Patient Index Data at 12 months
Time frame: 12 months
Percentage of participants with low disease activity based on the Clinical Disease Activity Index
Time frame: 6 months, 12 months
Percentage of participants with low disease activity based on the Routine Assessment Patient Index Data
Time frame: 6 months, 12 months
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) from baseline
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Change in Patient Health Questionnaire (PHQ-9) depression from baseline
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Change in Patient Global Assessment of disease activity (PGA) from baseline
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Change in Pain Visual Analogue Scale (VAS) from baseline
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Change in Fatigue Visual Analogue Scale (VAS) from baseline
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Change in SF-36 health status from baseline
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Change in Rheumatoid Arthritis Specific Work Productivity Survey (WPS-RA) from baseline
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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.
George A Karpouzas, MD principal investigator
The Lundquist Institute at Harbor-UCLA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rheumatoid arthritis educational booklet, Multidisciplinary rheumatologic care and Nurse education and monthly calls in people with Arthritis, Rheumatoid, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center 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 6 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: withdrawn, as of the sponsor's last update on 2 Jul 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percentage of participants achieving remission based on the Clinical Disease Activity Index at 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. 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 Jul 2026.