Multidisciplinary Care for Rheumatoid Arthritis

(MAPPIT-RA Trial)

Overseen By Elizabeth Hernandez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Disqualifiers: Irreversible articular damage, Functional class IV, Overlapping autoimmune, Serious medical conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to treating rheumatoid arthritis (RA) by combining multidisciplinary rheumatologic care from a team of experts, including doctors, nurses, and therapists, with technology to track symptoms at home. The goal is to determine if this method can help more people achieve remission (a state where RA symptoms are minimal or gone) within six months. Participants will receive either this special care or standard RA care to compare results. The trial seeks Hispanic adults living in the Greater Los Angeles area who have moderate RA symptoms and are already receiving care at a specific clinic. As an unphased trial, this study offers a unique opportunity to contribute to innovative RA treatment strategies and potentially improve personal health outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this multidisciplinary care approach is safe for rheumatoid arthritis patients?

Research has shown that a team-based approach to treating rheumatoid arthritis (RA) is generally safe. Studies have found that patients receiving care from a team of healthcare professionals, including doctors, nurses, physical therapists, and psychologists, often experience better health outcomes.

Most patients handle this type of care well, with few serious side effects reported. The main goal is to manage symptoms and improve quality of life, helping patients function better overall. While all treatments carry some risks, evidence suggests that this team-based care is both effective and well-tolerated for people with RA. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a comprehensive, multidisciplinary approach to managing rheumatoid arthritis (RA), which is different from the standard care that often involves only routine visits to a rheumatologist. This new approach includes not just regular check-ups with a rheumatologist, but also integrates evaluations by a physical therapist and a psychologist to address both physical and mental aspects of RA. Additionally, participants receive personalized follow-up through monthly calls and educational support, which could lead to more tailored and effective management of their condition. This method offers the potential for more proactive and holistic care, possibly improving quality of life for patients with RA.

What evidence suggests that this trial's treatments could be effective for rheumatoid arthritis?

Research has shown that a team-based approach can improve symptoms in people with rheumatoid arthritis (RA). In this trial, participants in the intervention arm will receive multidisciplinary rheumatologic care, involving specialists such as rheumatologists, physical therapists, and psychologists. One study found that patients who received care from a team of specialists had better symptom control for up to a year. Another study demonstrated that a lifestyle program involving various specialists led to significant improvements in RA. These programs typically include a team of experts who collaborate to provide comprehensive care. This approach not only focuses on medical treatment but also helps patients manage symptoms and enhance their overall quality of life. ^{2 6 7 8 9}

Who Is on the Research Team?

George A Karpouzas, MD

Principal Investigator

The Lundquist Institute at Harbor-UCLA Medical Center

Are You a Good Fit for This Trial?

This trial is for socioeconomically disadvantaged Hispanic adults in the Greater Los Angeles area with moderate to severe rheumatoid arthritis (RA), as defined by specific clinical scores. Participants must be able to consent, follow the study schedule, and have a phone. Those with other autoimmune conditions, serious joint damage or medical issues that could interfere are excluded.

Inclusion Criteria

Availability of a touch-tone landline or mobile telephone

Of self-identified Hispanic/Latino descent

Be able and willing to provide written informed consent and to adhere to the study visit schedule and other protocol

Exclusion Criteria

I have an autoimmune or mixed connective tissue condition.

Known irreversible articular damage, including subluxations, arthrodesis, fusion, or prosthesis

At risk for suicide

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants complete baseline measures and are randomly assigned to Intervention and Control arms

1 week

1 visit (in-person)

Treatment

Participants receive either standard care or a multifaceted intervention including multidisciplinary care, self-management education, and symptom monitoring

12 months

Quarterly visits (in-person), weekly symptom monitoring (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Monthly healthcare coordinator calls
• Multidisciplinary rheumatologic care
• Nurse education and monthly calls
• Rheumatoid arthritis educational booklet
• Technology-based symptom monitoring and reporting

Trial Overview The study tests a comprehensive RA treatment approach combining technology-based symptom monitoring at home, multidisciplinary care from healthcare professionals, nurse-led education and regular follow-ups against standard guideline-based care to see if it improves remission rates after 6 months.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 4 Interventions

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.

Group II: Control Arm Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Lead Sponsor

Trials

105

Recruited

46,600+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

In a study of 143 patients with rheumatoid arthritis (RA) and osteoarthritis (OA), 35.7% experienced adverse drug events (ADEs), highlighting the commonality of these events in patients taking medications for these conditions.

Most ADEs were linked to disease-modifying anti-rheumatic drugs (59.4%) and non-steroidal anti-inflammatory drugs (14.5%), with 44.1% of the ADEs deemed preventable, indicating a need for better monitoring and management of drug safety in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events in rheumatoid arthritis and osteoarthritis ambulatory patients. Tragulpiankit, P., Chulavatnatol, S., Rerkpattanapipat, T., et al.[2012]

Biologics have significantly improved the management of rheumatoid arthritis (RA) by selectively targeting the immune system, leading to better disease control, but they also raise safety concerns among doctors.

While randomized controlled trials (RCTs) provide some safety insights, they often don't reflect real-world safety issues due to strict study designs; in contrast, registries offer more reliable long-term safety data, though there is a lack of such data from Eastern Europe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of biologics in rheumatoid arthritis: data from randomized controlled trials and registries. Codreanu, C., Damjanov, N.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9680987/

Better Clinical Results in Rheumatoid Arthritis Patients ... To describe clinical characteristics and effectiveness of health care in patients with rheumatoid arthritis (RA) as part of a multidisciplinary ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/9355209/

Efficacy of Multidisciplinary Team Care Programs in ... Conclusion: Favorable effects on disease activity were seen in most trials comparing short inpatient team care with regular outpatient care. Proof of efficacy ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S004901729780011X

Efficacy of multidisciplinary team care programs in ... Inpatient programs (average duration, 10 to 28 days) had a direct favorable effect on disease activity, lasting up to 1 year. The effect of outpatient programs ...

4. acrjournals.onlinelibrary.wiley.com acrjournals.onlinelibrary.wiley.com/doi/10.1002/acr.25553

Two‐Year Follow‐Up of a Multidisciplinary Lifestyle ... In two randomized controlled trials the 16-week Plants for Joints (PFJ) multidisciplinary lifestyle intervention significantly improved disease ...

5. rmdopen.bmj.com rmdopen.bmj.com/content/10/1/e003483

Personalised care packages for people with rheumatoid ... A total of 41 complete responses were received: 17 (43%) rheumatology consultants, 7 (18%) specialist nurses, 6 (15%) rheumatology trainees, 5 ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12482164/

Resilience And Healthy Lifestyle for Rheumatoid Arthritis (The ... The aim of this trial is to assess the feasibility, effectiveness, acceptability and durability of a structured, multidisciplinary, ...

7. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-021-07138-0

Understanding multidisciplinary care for people with ... Nurses and rheumatologists experienced the multidisciplinary care model as providing improved patient health outcomes.

8. journals.lww.com journals.lww.com/co-rheumatology/Fulltext/2004/03000/Multidisciplinary_team_care_and_outcomes_in.15.aspx?generateEpub=Article%7Cco-rheumatology:2004:03000:00015%7C%7C

Multidisciplinary team care and outcomes in rheumatoid ... Comprehensive multidisciplinary team care programs for people with rheumatoid arthritis (RA) are aimed at improving overall functioning on the level of body ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7654306/

Clinical Outcomes of Patients with Rheumatoid Arthritis ... We have shown some benefits of DMP for improving the clinical status in patients with RA. Since systematic measurements of the disease activity ...