Evaluate Bone Changes in Patients With PsA

Patients will receive weekly abatacept (Orencia®) s.c. Abatacept in the dose regimen given in the label for RA and PsA for six months

Abatacept 125 MG/ML

University Clinic Erlangen, Medical Department 3, Rheumatology & Immunology

Abatacept Bone Effects in Psoriatic Arthritis With Bone Biomarker

Abatacept Bone Effects in Psoriatic Arthritis With Bone Biomarkers - ABEPSA _ BB

Change in bone erosion volume measured by Hr-PQ CT of the involved hand between baseline and 24 weeks follow-up

Change in bone erosion on CT between baseline and 24 wks

Change in osteophytes CT between baseline and 24 wks

Change in MRI Tenosynovitis score between baseline compared to month 3 and 6

Change in PSAMRIS MRI score between baseline compared to month 3 and 6

Change in MRI bone erosions between baseline compared to month 3 and month 6

Change in MRI synovitis between baseline compared to month 3 and month 6

Change of DAS28 between baseline compared to month 3 and month 6

Change of DAPSA between baseline compared to month 3 and month 6

Change of MDA between baseline compared to month 3 and month 6

Change of HAQ-DI between baseline compared to month 3 and month 6

Change of SPARCC between baseline compared to month 3 and month 6

Change of PSAID between baseline compared to month 3 and month 6

Change of PASI between baseline compared to month 3 and month 6

Change of SF36 between screening, month 3 and month 6

University of Erlangen-Nürnberg Medical School

The study is a single arm interventional study with a treatment phase of 6 months.

850 mg metformin twice daily for six months in addition to standard therapy

placebo in addition to standard therapy for rheumatoid arthritis

Rheumatoid Arthritis

metformin 850 mg bid for RA patients with moderate to high disease activity provided by DAS-28 score greater than 3.2

Metformin

methotrexate, leflunomide, hydroxychloroquine or sulfasalazine

Conventional DMARDs

Placebo Oral Tablet

Al-Zahraa University Hospital

Metformin Use in Rheumatoid Arthritis

The Effect of Metformin on the Clinical Outcome of Patients With Rheumatoid Arthritis

scale assessing severity of rheumatoid arthritis based on number of tender , swollen joints , ESR levels ,and patient self-assessment of his condition (global health assessment) . Whereas "28" describes the number of different joints including in the measurement :proximal interphalangeal joints (10 joints),metacarpophalangeal joints (10),wrists (2),elbows (2),shoulders (2),knees (2).
DAS28 values range from 2 to 10 while higher values mean a higher disease activity. A DAS-28 value < 2.6 corresponds to remission,value between 2.6 and 3.2 corresponds to a low disease activity, value between 3.2 and 5.1 corresponds to a moderate disease activity, and DAS28 value >5.1 corresponds to a high disease activity.

blood samples will be withdrawn at baseline and after 3 and 6 months to evaluate serum levels of C reactive protein

HAQ-DI (Health Assessment Score- Disability index), in which patients are asked to rate their capacity to perform 20 activities of daily living (ADL). Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section, The Standard Disability Index (DI) calculated as the sum of the scores for various subscales divided by the number of subscales responded to, and results in a score between 0 and 3.Whereas scores can be interpreted as:
From 0 to 1: mild difficulties to moderate disability, 2: moderate, 3: severe to very severe disability.

blood samples will be withdrawn at baseline and after 3 and 6 months to evaluate serum adiponetin levels using ELISA kits

adverse effect will be reported by patients or their caregivers and recorded by investigator

Mahmoud Mustafa Mahmoud Gharib

Principal investigator

Ain Shams University

Future University in Egypt

Patients randomized in this group will be treated with a combination of platelet-rich plasma plus hyaluronic acid prepared with A-CP HA Kit.

Patients randomized in this group will be treated with hyaluronic acid only (ArthroVisc 40); hyaluronic acid is the same as the one contained in the A-CP HA Kit.

Patients randomized in this group will be treated with a saline solution.

Knee Osteoarthritis

Patients randomized in this group will receive two injections of platelet-rich plasma/hyaluronic acid prepared with the A-CP HA Kit at Day 0 and Month 2

A-CP HA Kit

Patients randomized in this group will receive two injections of hyaluronic acid only (ArthroVisc 40) at Day 0 and Month 2

ArthroVisc 40

Patients randomized in this group will receive two injections of a saline placebo at Day 0 and Month 2

Placebo

Bert Mandelbaum, MD

Comparative Evaluation of A-CP HA Kit, Hyaluronic Acid and Placebo for the Treatment of Knee Osteoarthritis

Comparative Evaluation of the Performance and Safety of A-CP HA Kit, for the Preparation of a Combination of Platelet Rich Plasma and Hyaluronic Acid, Versus Hyaluronic Acid Alone and Placebo in Patients With Knee Osteoarthritis

It will be assessed by the mean difference in total WOMAC score on a 100-mm VAS between baseline and Month 6

II t will be assessed by the mean difference on a 100-mm VAS between baseline (D0) and Month 6

It will be assessed by the mean difference in total WOMAC score on a 100-mm VAS between baseline (D0) and Month 1, Month 2, Month 3, Month 4, and month 12.

It will be assessed by the mean difference in WOMAC A1 score on a 100-mm VAS between baseline (D0) and Month 1 (Day 30), Month 2, Month 3, Month 4, and Month 12

It will be assessed by the mean difference in total WOMAC A score on a 100-mm VAS between baseline (D0) and Month 1 (Day 30), Month 2, Month 3, Month 4, Month 6 and Month 12

It will be assessed by the mean difference in total WOMAC B score on a 100-mm VAS between baseline (D0) and Month 1 (Day 30), Month 2, Month 3, Month 4, Month 6 and Month 12

It will be assessed by the mean difference in total WOMAC C score on a 100-mm VAS between baseline (D0) and Month 1 (Day 30), Month 2, Month 3, Month 4, Month 6 and Month 12

It will be assessed at Month 1, Month 2, Mont 3, Month 4, Month 6, and Month 12

It will be assessed by the variation in the SF-36 questionnaire, between baseline (D0) and Month 1 (Day 30), Month 2, Month 3, Month 4, Month 6 and Month 12

Comparison of the use of rescue medication between the three groups of treatment at baseline, Month 1, Month 2, Month 3, Month 4, Month 6 and Month 12

antirheumatics/adipositas

Abatacept Bone Effects in Psoriatic Arthritis With Bone Biomarker

Metformin Use in Rheumatoid Arthritis

Comparative Evaluation of A-CP HA Kit, Hyaluronic Acid and Placebo for the Treatment of Knee Osteoarthritis

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