POISE: Psoriatic Oligoarthritis Intervention With Symptomatic thErapy

• Sponsor: University of Oxford (Other)
• Overall Status: Completed
• CT.gov ID: NCT03797872
• Collaborator: National Institute for Health Research, United Kingdom (Other)
• Enrollment: 1
• Location: 1
• Arms: 2
• Actual Duration (Months): 15
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

POISE is a two arm interventional trial nested within a cohort (Trials Within Cohorts or TWiCs design). This tests less aggressive early therapy in patients newly diagnosed with low impact oligoarticular PsA. Arm 1 will receive standard step up therapy in the cohort and act as the control group. Arm 2 will receive local steroid injections to active joints and will be able to use non-steroidal anti-inflammatory drugs (NSAIDs) only

Condition or Disease	Intervention/Treatment	Phase
Psoriatic Arthritis	Drug: Methotrexate; Drug: Sulfasalazine; Drug: Leflunomide; Drug: Methylprednisolone; Drug: Triamcinolone	Phase 4

Detailed Description

Arm 1: Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard practice in these PsA clinics following current international recommendations and National requirements for the prescription of biologic therapy. Whilst physician discretion is used, most commonly Initial therapy will be with methotrexate alone (15mg/week rising to 25mg/week as tolerated by week 8 of therapy) unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (most commonly sulfasalazine or leflunomide) added or switched to at the discretion of the rheumatologist. In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations usually with a TNF inhibitor as first line. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used. Further details are available in the PsA clinic treatment protocol which is Appendix D in the MONITOR-PsA protocol.

Arm 2: Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local glucocorticoid injections to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication as indicated for individuals. Local glucocorticoid injections will include injections with methylprednisolone or triamcinolone. All active joints will be treated with glucocorticoid injections. Glucocorticoid injections can be either be given as an intra-articular injection to an inflamed joint or as an intra-muscular injection if multiple joints are involved. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy). If Participants require DMARD therapy, they will be offered rescue therapy as per usual clinical care but will be asked to continue with data collection for the trial. This is to ensure that sufficient data is collected for the trial but risks in delaying treatment to the individual are mitigated.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Blinded assessor will perform clinical evaluations
• Primary Purpose: Treatment
• Official Title: Clinical Effectiveness of Symptomatic Therapy Compared to Standard Step up Care for the Treatment of Low Impact Psoriatic Oligoarthritis: a 2 Arm Parallel Group Feasibility Study
• Actual Study Start Date: Apr 17, 2019
• Actual Primary Completion Date: Jul 16, 2020
• Actual Study Completion Date: Jul 16, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard care Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.	Drug: Methotrexate; Methotrexate up to 25mg/week as tolerated po or sc; Other Names: methotrexate sodium ; Drug: Sulfasalazine; Sulfasalazine up to 3g daily po; Other Names: sulfasalazine pill ; Drug: Leflunomide; Leflunomide 10-20mg daily po; Other Names: leflunomide pill
Experimental: Local/IM steroid injections Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy).	Drug: Methylprednisolone; For IA or IM injection 20-120mg; Other Names: methylprednisolone acetate ; Drug: Triamcinolone; For IA or IM injection 20-120mg; Other Names: triamcinolone acetonide

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study [48 weeks]

   To establish acceptability of this treatment approach assessing proportion of patients who are eligible, consent and complete the 48 week study. We will examine how many patients in the MONITOR cohort are eligible per year. All eligible patients in the MONITOR cohort will be approached and invited to join the study. We will then review how many patients complete the 48 week study period attending all visits from baseline to 48 weeks (0, 12, 24, 36 and 48).

Secondary Outcome Measures

1. Psoriatic Arthritis Disease Activity Score (PASDAS) [48 weeks]

   A composite measure of PsA disease activity. This score is a composite measure of disease activity in PsA. There is only one total score which ranges from 0-10 with higher numbers indicating more active disease. Low disease activity is defined as <3.2.

2. Ultrasound Score of Synovitis [0 weeks]

   A summary score of synovitis measured at baseline. The score will comprise of 23 joints bilaterally. Grey scale synovitis is scored at each site 0-3 and power doppler is also scored 0-3 at each site where higher scores indicate more severe disease. These scores are then summed to give a final score. Score range is 0-276

3. Ultrasound Score of Enthesitis [0 weeks]

   A summary score of enthesitis measured at baseline. The score will comprise of 5 entheses bilaterally. Power doppler is scored 0-3 at each site where higher scores indicate more severe disease activity. Calcifications, enthesophytes and grey scale abnormalities will each be score 0 (absent) or 1 (present) at each site. These scores are then summed to give a final score. Score range is 0-30

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants consented to the PsA inception cohort (MONITOR-PsA) and to be approached for alternate interventional therapies.

• Participants with mild disease as defined by:

• Oligoarticular disease with <5 active joints at baseline assessment.

• Low disease activity as defined by a PsA disease activity score (PASDAS) ≤3.2.

• Low impact of disease as defined a PsA impact of disease (PSAID) ≤4.

• Participant is willing and able to give informed consent for participation in the trial.

• Male or female.

• Aged 18 years or above.

• Female Participants of child bearing potential and male Participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception (defined as true abstinence, oral contraceptives, implants, intrauterine device, barrier method with spermicide, or surgical sterilization) during the trial and for 3 months thereafter if receiving DMARD therapy (excluding sulfasalazine).

• Participant has clinically acceptable laboratory results within 6 weeks of enrolment:

• Haemoglobin count > 8.5 g/dL

• White blood count (WBC) > 3.5 x 109/L

• Absolute neutrophil count (ANC) > 1.5 x 109/L

• Platelet count > 100 x 109/L

• ALT and alkaline phosphatase levels <3 x upper limit of normal

• In the Investigator's opinion, is able and willing to comply with all trial requirements.

• Willing to allow his or her GP and consultant, if appropriate, to be notified of participation in the trial.

Exclusion Criteria:

• ≥1 poor prognostic factors for psoriatic arthritis, from

• raised C reactive protein (CRP) defined as > 4g/dl for standard non-hsCRP

• radiographic damage defined as the presence of ≥ 1 erosion on plain radiographs of the hands and feet

• health assessment questionnaire (HAQ) score > 1

• Contraindications to non-steroidal anti-inflammatory drugs

• Previous treatment for articular disease with synthetic DMARDs (including methotrexate, leflunomide or sulfasalazine) or biologic DMARDs (including TNF, IL12/23 or IL17 inhibitor therapies) or targeted synthetic DMARDs (PDE4 of JAK inhibitor therapies).

• Female patient who is pregnant, breast feeding or planning pregnancy during the course of the trial.

• Significant renal or hepatic impairment.

• Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.

• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patients at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

• Patients who have participated in another research trial involving an investigational product in the past 12 weeks.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oxford University Hospitals NHS Trust	Oxford	Oxfordshire	United Kingdom	OX3 7LD

Sponsors and Collaborators

• University of Oxford
• National Institute for Health Research, United Kingdom

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 27, 2019

More Information

Publications

None provided.

• Responsible Party: University of Oxford
• ClinicalTrials.gov Identifier: NCT03797872
• Other Study ID Numbers: 18/SC/0261
• First Posted: Jan 9, 2019
• Last Update Posted: May 10, 2021
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Arthritis, Psoriatic; Sulfasalazine; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Methotrexate; Triamcinolone diacetate; Leflunomide; Prednisolone hemisuccinate; Prednisolone phosphate

Study Results

Participant Flow

Recruitment Details	The POISE trial opened on 17 April 2019 in Oxford and 19 September 2019 in Bath. The study remained open until 16 July 2020 as planned.

Arm/Group Title	Standard Care	Local/IM Steroid Injections
Arm/Group Description	Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used. Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc Sulfasalazine: Sulfasalazine up to 3g daily po Leflunomide: Leflunomide 10-20mg daily po	Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy). Methylprednisolone: For IA or IM injection 20-120mg Triamcinolone: For IA or IM injection 20-120mg
Period Title: Overall Study
STARTED	1	0
COMPLETED	0	0
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Standard Care	Local/IM Steroid Injections	Total
Arm/Group Description	Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used. Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc Sulfasalazine: Sulfasalazine up to 3g daily po Leflunomide: Leflunomide 10-20mg daily po	Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy). Methylprednisolone: For IA or IM injection 20-120mg Triamcinolone: For IA or IM injection 20-120mg	Total of all reporting groups
Overall Participants	1	0	1
Age (Count of Participants)
<=18 years	0 0%	0 NaN	0 0%
Between 18 and 65 years	1 100%	0 NaN	1 100%
>=65 years	0 0%	0 NaN	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 NaN	0 0%
Male	1 100%	0 NaN	1 100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United Kingdom	1 100%	1 Infinity

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Are Eligible, Consent, and Complete the 48 Weeks Study
Description	To establish acceptability of this treatment approach assessing proportion of patients who are eligible, consent and complete the 48 week study. We will examine how many patients in the MONITOR cohort are eligible per year. All eligible patients in the MONITOR cohort will be approached and invited to join the study. We will then review how many patients complete the 48 week study period attending all visits from baseline to 48 weeks (0, 12, 24, 36 and 48).
Time Frame	48 weeks

Outcome Measure Data

Analysis Population Description

All participants included

Arm/Group Title	Standard Care	Local/IM Steroid Injections
Arm/Group Description	Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used. Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc Sulfasalazine: Sulfasalazine up to 3g daily po Leflunomide: Leflunomide 10-20mg daily po	Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy). Methylprednisolone: For IA or IM injection 20-120mg Triamcinolone: For IA or IM injection 20-120mg
Measure Participants	1	0
Count of Participants [Participants]	0 0%

2. Secondary Outcome

Title	Psoriatic Arthritis Disease Activity Score (PASDAS)
Description	A composite measure of PsA disease activity. This score is a composite measure of disease activity in PsA. There is only one total score which ranges from 0-10 with higher numbers indicating more active disease. Low disease activity is defined as <3.2.
Time Frame	48 weeks

Outcome Measure Data

Analysis Population Description

Only one patient was recruited and he was lost to follow up before 48 weeks thus these data are not available for analysis

Arm/Group Title	Standard Care	Local/IM Steroid Injections
Arm/Group Description	Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used. Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc Sulfasalazine: Sulfasalazine up to 3g daily po Leflunomide: Leflunomide 10-20mg daily po	Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy). Methylprednisolone: For IA or IM injection 20-120mg Triamcinolone: For IA or IM injection 20-120mg
Measure Participants	0	0

3. Secondary Outcome

Title	Ultrasound Score of Synovitis
Description	A summary score of synovitis measured at baseline. The score will comprise of 23 joints bilaterally. Grey scale synovitis is scored at each site 0-3 and power doppler is also scored 0-3 at each site where higher scores indicate more severe disease. These scores are then summed to give a final score. Score range is 0-276
Time Frame	0 weeks

Outcome Measure Data

Analysis Population Description

Only one patient was recruited and he was lost to follow up before 48 weeks thus these data are not available for analysis

Arm/Group Title	Standard Care	Local/IM Steroid Injections
Arm/Group Description	Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used. Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc Sulfasalazine: Sulfasalazine up to 3g daily po Leflunomide: Leflunomide 10-20mg daily po	Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy). Methylprednisolone: For IA or IM injection 20-120mg Triamcinolone: For IA or IM injection 20-120mg
Measure Participants	0	0

4. Secondary Outcome

Title	Ultrasound Score of Enthesitis
Description	A summary score of enthesitis measured at baseline. The score will comprise of 5 entheses bilaterally. Power doppler is scored 0-3 at each site where higher scores indicate more severe disease activity. Calcifications, enthesophytes and grey scale abnormalities will each be score 0 (absent) or 1 (present) at each site. These scores are then summed to give a final score. Score range is 0-30
Time Frame	0 weeks

Outcome Measure Data

Analysis Population Description

Only one patient was recruited and he was lost to follow up before 48 weeks thus these data are not available for analysis. The US was not performed as this was only for participants in the intervention group.

Arm/Group Title	Standard Care	Local/IM Steroid Injections
Arm/Group Description	Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used. Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc Sulfasalazine: Sulfasalazine up to 3g daily po Leflunomide: Leflunomide 10-20mg daily po	Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy). Methylprednisolone: For IA or IM injection 20-120mg Triamcinolone: For IA or IM injection 20-120mg
Measure Participants	0	0

Adverse Events

Time Frame	48 week study
Adverse Event Reporting Description	48 week study
Arm/Group Title	Standard Care		Local/IM Steroid Injections
Arm/Group Description	Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice. Commonly Initial therapy will be with methotrexate alone unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (sulfasalazine or leflunomide). In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used. Methotrexate: Methotrexate up to 25mg/week as tolerated po or sc Sulfasalazine: Sulfasalazine up to 3g daily po Leflunomide: Leflunomide 10-20mg daily po		Symptomatic therapy arm. The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local injections of methylprednisolone or triamcinolone to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication. All active joints will be treated with injections. Injections can be either be given as an intra-articular injection or as an intra-muscular injection. If any joint requires more than 2 local injections of glucocorticoid within a 6 month period, then the patient is deemed to have failed symptomatic therapy and will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with DMARD therapy). Methylprednisolone: For IA or IM injection 20-120mg Triamcinolone: For IA or IM injection 20-120mg
All Cause Mortality
	Standard Care		Local/IM Steroid Injections
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)
Serious Adverse Events
	Standard Care		Local/IM Steroid Injections
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Standard Care		Local/IM Steroid Injections
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)

Limitations/Caveats

Only 1 participants was eligible and participated in the trial during the recruitment period and this patient was lost to follow up after the baseline visit.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.