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Compensation: Varies

Number of Visits: 1

Duration: 12 months

150 Participants Needed

Multidisciplinary Care for Rheumatoid Arthritis
(MAPPIT-RA Trial)

Overseen ByElizabeth 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 GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Multidisciplinary Care for Rheumatoid Arthritis?

Research shows that multidisciplinary care, which involves a team of health professionals, is effective in managing rheumatoid arthritis. It can achieve similar outcomes to regular care but at lower costs, especially when coordinated by a skilled clinical nurse specialist.¹ ² ³ ⁴ ⁵

Is multidisciplinary care for rheumatoid arthritis safe for humans?

The research does not provide specific safety data for multidisciplinary care approaches like monthly healthcare coordinator calls or nurse education. However, these methods generally involve coordination and education rather than medication, suggesting they are likely safe for humans.⁶ ⁷ ⁸ ⁹ ¹⁰

How is multidisciplinary rheumatologic care different from other treatments for rheumatoid arthritis?

Multidisciplinary rheumatologic care is unique because it involves a team of various health professionals working together to manage rheumatoid arthritis, focusing on coordination and specialized skills rather than just the number of professionals involved. This approach can improve patient outcomes by addressing healthcare needs that a single rheumatologist might not meet alone.¹ ² ³ ⁹ ¹¹

Research Team

George KARPOUZAS | Professor | Research ...

George A Karpouzas, MD

Principal Investigator

The Lundquist Institute at Harbor-UCLA Medical Center

Eligibility Criteria

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

See 3 more

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

See 2 more

Timeline

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

Treatment Details

Interventions

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

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention ArmExperimental Treatment4 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 ArmActive Control2 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.

Find a Clinic Near You

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

Findings from Research

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]

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]