Rheumatoid ArthritisRA-DietNCT05291299
Anti-Inflammatory Dietary Intervention for Rheumatoid Arthritis
A study testing Anti-inflammatory diet in people with Rheumatoid Arthritis, run by Attune Health Research, Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to assess if there is a significant difference in the mean disease activity score in individuals with RA participating in a dietary intervention compared to those in the control group measured by DAS-28. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Anti-inflammatory diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2022to Mar 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
- Age greater than 18 years.
- Diagnosed RA by a rheumatologist determined by the 2010 ACR/EULAR Classification Criteria.
- Low, moderate, or highly active disease state based on clinical assessment where the investigator feels there is potential to see a difference.
- Able to read and write in English.
Who cannot join
- Younger than 18 years.
- Unable to attend the 8 weekly nutrition appointment.
- History of documented eating disorders.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Attune Health Research Inc
Beverly Hills, California, 90211
Natalie Fortune, MS, 131-065-2001, research.Admin@attunehealth.com
About this study
The primary objective of this study is to assess if there is a significant difference in the mean disease activity score in individuals with RA participating in a dietary intervention compared to those in the control group measured by DAS-28. Other measures to track disease activity will include monitoring number and severity of disease flares and any changes in medications. This will be done by completing a single-blinded randomized controlled trial, parallel in design. The study population will consist of adults diagnosed with Seropositive and Seronegative RA based on the American College of Rheumatology criteria. Participants will have low, moderate, or high disease activity based on DAS-28 where the investigator feels that they can see improvement from a dietary intervention.
Read the detailed description
Per the Schedule of Assessments, upon enrollment, participants will be required to come in for a total of five on site visits. The first visit, also known as the baseline visit, will require participants to provided informed consent after all eligibility criteria is met. Subsequently, participants' Demographics, Medical History, EULAR/ACR classification, and physicians' assessments will be documented. Participants' vital signs will be checked and a thorough physical exam will also be performed after which safety labs will be drawn in addition to a routine urinalysis. Participants will complete outcome surveys and a food frequency questionnaire. Participants' body composition will be measured. Concomitant medications will be reviewed. Each participant will receive nutrition education from an approved MD or a consultation with an approved RD depending on the group to which they have been randomized. Participants who receive consultations with an RD will have seven follow up visits after the baseline visit.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Anti-inflammatory diet, Control/Standard of Care
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-inflammatory dietBehavioural
Patients randomized to the intervention group will work with a registered dietitian to create an individualized diet program to help reduce inflammation and Rheumatoid arthritis related symptoms.
Control/Standard of CareOther
Patients randomized to the control group will be following standard of care where their doctor will instruct them to follow a Mediterranean diet and provides them with an instructional sheet.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (Control Group) | Other | Physicians will follow standard of care and instruct participants in the control group to follow a Mediterranean diet higher in vegetables and fruits[19]. Patients will be provided with a handout detailing the basics of the Mediterranean diet. At follow up visits, physicians will ask participants about how they have been eating and if they have been following the guidelines. Receives: Other: Control/Standard of Care |
| Anti-inflammatory Diet (Intervention Group) | Experimental | An 8-week nutrition program consisting of an individualized elimination diet and systematic food reintroduction implemented and supervised by a Registered Dietitian. Clinical trials have shown some benefit from elimination diets for individuals with autoimmune disease [18].
The specifics of the elimination diet including duration and foods included will be individual and up to the RDs discretion based on the patient's medical and diet history, willingness, current diet, preferences, goals, and ability. The initial diet instruction with a Registered Dietitian will be a one-hour, individual secure video call, with nutrition evaluation/assessment and education on elimination diet protocol. Follow up visits will be approximately 20-30 minutes for the subsequent 7 weeks. Receives: Behavioral: Anti-inflammatory diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Activity
Rheumatoid arthritis disease activity Measured by Disease Activity Score-28, higher score is associated with increased disease activity. a Disease Activity Score greater than 5.1 indicated very active disease while a Disease Activity Score that is lower than 2.6 indicates disease remission
Measured: 8 weeks
Disease Activity
Rheumatoid arthritis disease activity Measured by Disease Activity Score-28, higher score is associated with increased disease activity. a Disease Activity Score greater than 5.1 indicated very active disease while a Disease Activity Score that is lower than 2.6 indicates disease remission
Measured: 52 weeks
Secondary outcomes (10)
Patient reported outcomes
change in patient reported disease related outcomes measured by Health Assessment Questionaire-Disability Index, where a higher score indicates lower quality of health. A 0 indicates no difficulty in task performance while a score of 3 indicates much difficulty in task performance
Measured: 8 weeks
Patient reported outcomes
change in patient reported disease related outcomes measured by Health Assessment Questionaire-Disability Index, where a higher score indicates lower quality of health. A 0 indicates no difficulty in task performance while a score of 3 indicates much difficulty in task performance
Measured: 52 weeks
Patient reported outcomes
change in patient reported disease related outcomes measured by Physical and Mental Health Summary Score (PROMIS-29) where a score of 0 indicates excellent mental and physical health while a score of 10 indicates poor mental and physical health.
Measured: 8 weeks
Patient reported outcomes
change in patient reported disease related outcomes measured by Physical and Mental Health Summary Score (PROMIS-29) where a score of 0 indicates excellent mental and physical health while a score of 10 indicates poor mental and physical health.
Measured: 52 weeks
Anthropometric measurements
Assess the change in anthropometric measurements by weight
Measured: 8 weeks
Anthropometric measurements
Assess the change in anthropometric measurements by weight
Measured: 52 weeks
Anthropometric measurements
Assess the change in anthropometric measurements by body fat percentage (waist circumference)
Measured: 8 weeks
Anthropometric measurements
Assess the change in anthropometric measurements by body fat percentage (waist circumference)
Measured: 52 weeks
Anthropometric measurements
Assess the change in anthropometric measurements by waist/hip ratio
Measured: 8 weeks
Anthropometric measurements
Assess the change in anthropometric measurements by waist/hip ratio
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start5 Jul 2022
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Attune Health Research, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cedars-Sinai Medical Center
- Responsible party
- Principal investigator, Swamy Venuturupalli, Attune Health Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291299
- Sponsor's protocol ID
- 227188
- Acronym
- RA-Diet
- Status last verified
- Jul 2023
- First submitted
- 27 Jan 2022
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen YM, Chen HH, Hsieh CW, Hsieh TY, Lan JL, Chen DY. A close association of body cell mass loss with disease activity and disability in Chinese patients with rheumatoid arthritis. Clinics (Sao Paulo). 2011;66(7):1217-22. doi: 10.1590/s1807-59322011000700016.
PubMed 21876977Tajik N, Frech M, Schulz O, Schalter F, Lucas S, Azizov V, Durholz K, Steffen F, Omata Y, Rings A, Bertog M, Rizzo A, Iljazovic A, Basic M, Kleyer A, Culemann S, Kronke G, Luo Y, Uberla K, Gaipl US, Frey B, Strowig T, Sarter K, Bischoff SC, Wirtz S, Canete JD, Ciccia F, Schett G, Zaiss MM. Targeting zonulin and intestinal epithelial barrier function to prevent onset of arthritis. Nat Commun. 2020 Apr 24;11(1):1995. doi: 10.1038/s41467-020-15831-7.
PubMed 32332732de Carvalho MR, Tebexreni AS, Salles CA, Barros Neto T, Natour J. Oxygen uptake during walking in patients with rheumatoid arthritis--a controlled study. J Rheumatol. 2004 Apr;31(4):655-62.
PubMed 15088289Guerreiro CS, Calado A, Sousa J, Fonseca JE. Diet, Microbiota, and Gut Permeability-The Unknown Triad in Rheumatoid Arthritis. Front Med (Lausanne). 2018 Dec 14;5:349. doi: 10.3389/fmed.2018.00349. eCollection 2018.
PubMed 30619860Zhong D, Wu C, Zeng X, Wang Q. The role of gut microbiota in the pathogenesis of rheumatic diseases. Clin Rheumatol. 2018 Jan;37(1):25-34. doi: 10.1007/s10067-017-3821-4. Epub 2017 Sep 15.
PubMed 28914372Paolino S, Pacini G, Patane M, Alessandri E, Cattelan F, Goegan F, Pizzorni C, Gotelli E, Cutolo M. Interactions between microbiota, diet/nutrients and immune/inflammatory response in rheumatic diseases: focus on rheumatoid arthritis. Reumatologia. 2019;57(3):151-157. doi: 10.5114/reum.2019.86425. Epub 2019 Jun 28.
PubMed 31462830Gioia C, Lucchino B, Tarsitano MG, Iannuccelli C, Di Franco M. Dietary Habits and Nutrition in Rheumatoid Arthritis: Can Diet Influence Disease Development and Clinical Manifestations? Nutrients. 2020 May 18;12(5):1456. doi: 10.3390/nu12051456.
PubMed 32443535Leeming ER, Johnson AJ, Spector TD, Le Roy CI. Effect of Diet on the Gut Microbiota: Rethinking Intervention Duration. Nutrients. 2019 Nov 22;11(12):2862. doi: 10.3390/nu11122862.
PubMed 31766592Camilleri M, Lyle BJ, Madsen KL, Sonnenburg J, Verbeke K, Wu GD. Role for diet in normal gut barrier function: developing guidance within the framework of food-labeling regulations. Am J Physiol Gastrointest Liver Physiol. 2019 Jul 1;317(1):G17-G39. doi: 10.1152/ajpgi.00063.2019. Epub 2019 May 24.
PubMed 31125257Kjeldsen-Kragh J, Haugen M, Borchgrevink CF, Laerum E, Eek M, Mowinkel P, Hovi K, Forre O. Controlled trial of fasting and one-year vegetarian diet in rheumatoid arthritis. Lancet. 1991 Oct 12;338(8772):899-902. doi: 10.1016/0140-6736(91)91770-u.
PubMed 1681264Khanna S, Jaiswal KS, Gupta B. Managing Rheumatoid Arthritis with Dietary Interventions. Front Nutr. 2017 Nov 8;4:52. doi: 10.3389/fnut.2017.00052. eCollection 2017.
PubMed 29167795Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.
PubMed 20872595Shadick NA, Sowell NF, Frits ML, Hoffman SM, Hartz SA, Booth FD, Sweezy M, Rogers PR, Dubin RL, Atkinson JC, Friedman AL, Augusto F, Iannaccone CK, Fossel AH, Quinn G, Cui J, Losina E, Schwartz RC. A randomized controlled trial of an internal family systems-based psychotherapeutic intervention on outcomes in rheumatoid arthritis: a proof-of-concept study. J Rheumatol. 2013 Nov;40(11):1831-41. doi: 10.3899/jrheum.121465. Epub 2013 Aug 15.
PubMed 23950186Darlington LG, Ramsey NW, Mansfield JR. Placebo-controlled, blind study of dietary manipulation therapy in rheumatoid arthritis. Lancet. 1986 Feb 1;1(8475):236-8. doi: 10.1016/s0140-6736(86)90774-9.
PubMed 2868255Anderson J, Caplan L, Yazdany J, Robbins ML, Neogi T, Michaud K, Saag KG, O'Dell JR, Kazi S. Rheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practice. Arthritis Care Res (Hoboken). 2012 May;64(5):640-7. doi: 10.1002/acr.21649.
PubMed 22473918
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Inflammatory Dietary Intervention for Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05291299
- Acronym / sponsor ID
- RA-Diet / 227188
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Attune Health Research, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cedars-Sinai Medical Center
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 22 Mar 2022 (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.
The primary objective of this study is to assess if there is a significant difference in the mean disease activity score in individuals with RA participating in a dietary intervention compared to those in the control group measured by DAS-28. Other measures to track disease activity will include monitoring number and severity of disease flares and any changes in medications. This will be done by completing a single-blinded randomized controlled trial, parallel in design. The study population will consist of adults diagnosed with Seropositive and Seronegative RA based on the American College of Rheumatology criteria. Participants will have low, moderate, or high disease activity based on DAS-28 where the investigator feels that they can see improvement from a dietary intervention.
Detailed description
Per the Schedule of Assessments, upon enrollment, participants will be required to come in for a total of five on site visits. The first visit, also known as the baseline visit, will require participants to provided informed consent after all eligibility criteria is met. Subsequently, participants' Demographics, Medical History, EULAR/ACR classification, and physicians' assessments will be documented. Participants' vital signs will be checked and a thorough physical exam will also be performed after which safety labs will be drawn in addition to a routine urinalysis. Participants will complete outcome surveys and a food frequency questionnaire. Participants' body composition will be measured. Concomitant medications will be reviewed. Each participant will receive nutrition education from an approved MD or a consultation with an approved RD depending on the group to which they have been randomized. Participants who receive consultations with an RD will have seven follow up visits after the baseline visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (Control Group) | Other | Other: Control/Standard of CarePhysicians will follow standard of care and instruct participants in the control group to follow a Mediterranean diet higher in vegetables and fruits[19]. Patients will be provided with a handout detailing the basics of the Mediterranean diet. At follow up visits, physicians will ask participants about how they have been eating and if they have been following the guidelines. |
| Anti-inflammatory Diet (Intervention Group) | Experimental | Behavioral: Anti-inflammatory dietAn 8-week nutrition program consisting of an individualized elimination diet and systematic food reintroduction implemented and supervised by a Registered Dietitian. Clinical trials have shown some benefit from elimination diets for individuals with autoimmune disease [18]. The specifics of the elimination diet including duration and foods included will be individual and up to the RDs discretion based on the patient's medical and diet history, willingness, current diet, preferences, goals, and ability. The initial diet instruction with a Registered Dietitian will be a one-hour, individual secure video call, with nutrition evaluation/assessment and education on elimination diet protocol. Follow up visits will be approximately 20-30 minutes for the subsequent 7 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than 18 years.
- Diagnosed RA by a rheumatologist determined by the 2010 ACR/EULAR Classification Criteria.
- Low, moderate, or highly active disease state based on clinical assessment where the investigator feels there is potential to see a difference.
- Able to read and write in English.
Key exclusion criteria (3 listed)
- Younger than 18 years.
- Unable to attend the 8 weekly nutrition appointment.
- History of documented eating disorders.
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 |
|---|---|---|
| Anti-inflammatory dietPatients randomized to the intervention group will work with a registered dietitian to create an individualized diet program to help reduce inflammation and Rheumatoid arthritis related symptoms. | Behavioural | Anti-inflammatory Diet (Intervention Group) |
| Control/Standard of CarePatients randomized to the control group will be following standard of care where their doctor will instruct them to follow a Mediterranean diet and provides them with an instructional sheet. | Other | Standard of Care (Control Group) |
Primary outcome
Disease Activity
Time frame: 8 weeks
Rheumatoid arthritis disease activity Measured by Disease Activity Score-28, higher score is associated with increased disease activity. a Disease Activity Score greater than 5.1 indicated very active disease while a Disease Activity Score that is lower than 2.6 indicates disease remission
Disease Activity
Time frame: 52 weeks
Rheumatoid arthritis disease activity Measured by Disease Activity Score-28, higher score is associated with increased disease activity. a Disease Activity Score greater than 5.1 indicated very active disease while a Disease Activity Score that is lower than 2.6 indicates disease remission
10 secondary outcomes
Patient reported outcomes
Time frame: 8 weeks
Patient reported outcomes
Time frame: 52 weeks
Patient reported outcomes
Time frame: 8 weeks
Patient reported outcomes
Time frame: 52 weeks
Anthropometric measurements
Time frame: 8 weeks
Anthropometric measurements
Time frame: 52 weeks
Anthropometric measurements
Time frame: 8 weeks
Anthropometric measurements
Time frame: 52 weeks
Anthropometric measurements
Time frame: 8 weeks
Anthropometric measurements
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Background: PubMed 21876977Chen YM, Chen HH, Hsieh CW, Hsieh TY, Lan JL, Chen DY. A close association of body cell mass loss with disease activity and disability in Chinese patients with rheumatoid arthritis. Clinics (Sao Paulo). 2011;66(7):1217-22. doi: 10.1590/s1807-59322011000700016.
- Background: PubMed 32332732Tajik N, Frech M, Schulz O, Schalter F, Lucas S, Azizov V, Durholz K, Steffen F, Omata Y, Rings A, Bertog M, Rizzo A, Iljazovic A, Basic M, Kleyer A, Culemann S, Kronke G, Luo Y, Uberla K, Gaipl US, Frey B, Strowig T, Sarter K, Bischoff SC, Wirtz S, Canete JD, Ciccia F, Schett G, Zaiss MM. Targeting zonulin and intestinal epithelial barrier function to prevent onset of arthritis. Nat Commun. 2020 Apr 24;11(1):1995. doi: 10.1038/s41467-020-15831-7.
- Background: PubMed 15088289de Carvalho MR, Tebexreni AS, Salles CA, Barros Neto T, Natour J. Oxygen uptake during walking in patients with rheumatoid arthritis--a controlled study. J Rheumatol. 2004 Apr;31(4):655-62.
- Background: PubMed 30619860Guerreiro CS, Calado A, Sousa J, Fonseca JE. Diet, Microbiota, and Gut Permeability-The Unknown Triad in Rheumatoid Arthritis. Front Med (Lausanne). 2018 Dec 14;5:349. doi: 10.3389/fmed.2018.00349. eCollection 2018.
- Background: PubMed 28914372Zhong D, Wu C, Zeng X, Wang Q. The role of gut microbiota in the pathogenesis of rheumatic diseases. Clin Rheumatol. 2018 Jan;37(1):25-34. doi: 10.1007/s10067-017-3821-4. Epub 2017 Sep 15.
- Background: PubMed 31462830Paolino S, Pacini G, Patane M, Alessandri E, Cattelan F, Goegan F, Pizzorni C, Gotelli E, Cutolo M. Interactions between microbiota, diet/nutrients and immune/inflammatory response in rheumatic diseases: focus on rheumatoid arthritis. Reumatologia. 2019;57(3):151-157. doi: 10.5114/reum.2019.86425. Epub 2019 Jun 28.
- Background: PubMed 32443535Gioia C, Lucchino B, Tarsitano MG, Iannuccelli C, Di Franco M. Dietary Habits and Nutrition in Rheumatoid Arthritis: Can Diet Influence Disease Development and Clinical Manifestations? Nutrients. 2020 May 18;12(5):1456. doi: 10.3390/nu12051456.
- Background: PubMed 31766592Leeming ER, Johnson AJ, Spector TD, Le Roy CI. Effect of Diet on the Gut Microbiota: Rethinking Intervention Duration. Nutrients. 2019 Nov 22;11(12):2862. doi: 10.3390/nu11122862.
- Background: PubMed 31125257Camilleri M, Lyle BJ, Madsen KL, Sonnenburg J, Verbeke K, Wu GD. Role for diet in normal gut barrier function: developing guidance within the framework of food-labeling regulations. Am J Physiol Gastrointest Liver Physiol. 2019 Jul 1;317(1):G17-G39. doi: 10.1152/ajpgi.00063.2019. Epub 2019 May 24.
- Background: PubMed 1681264Kjeldsen-Kragh J, Haugen M, Borchgrevink CF, Laerum E, Eek M, Mowinkel P, Hovi K, Forre O. Controlled trial of fasting and one-year vegetarian diet in rheumatoid arthritis. Lancet. 1991 Oct 12;338(8772):899-902. doi: 10.1016/0140-6736(91)91770-u.
- Background: PubMed 29167795Khanna S, Jaiswal KS, Gupta B. Managing Rheumatoid Arthritis with Dietary Interventions. Front Nutr. 2017 Nov 8;4:52. doi: 10.3389/fnut.2017.00052. eCollection 2017.
- Background: PubMed 20872595Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-inflammatory diet in people with Rheumatoid Arthritis, run by Attune Health Research, Inc. 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natalie Fortune, MS (3106520010, research.admin@attunehealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Activity (time frame: 8 weeks). 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?
On the ClinicalTrials.gov record for NCT05291299, which also lists 21 linked publications.
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 19 Jul 2023.