Metformin in Psoriatic Arthritis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02188654 |
Recruitment Status :
Completed
First Posted : July 11, 2014
Last Update Posted : July 11, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Psoriatic Arthritis | Drug: Metformin Drug: Placebo | Not Applicable |
The chronic inflammatory nature of psoriasis and PsA predisposes patients to cardiovascular diseases and metabolic syndrome (MetS). MetS is associated with systemic inflammation and proinflammatory cytokines.Clinical observations and experimental results argue for an anti-inflammatory and immunosuppressant property of MET.
A randomized placebo-controlled trial was conducted to evaluate the efficacy and safety of metformin as add-on therapy to MTX compared to MTX after 24 weeks in patients with PsA.
The study randomized 56 patients with a diagnosis of PsA . Patients with a history of a cardiovascular event and diabetics were excluded. Body mass index (BMI) and classic cardiovascular risk factors were recorded. Blood samples were analysed for glucose, lipid profile, ESR, hsCRP, proinflammatory cytokines; tumour necrosis factor alpha (TNF-alpha), interleukin-6 (IL-6) and IL-17. The homeostasis model assessment model for insulin resistance (HOMA-IR) was used. The patients were randomized in a 1:1 ratio to receive 500mg/day retarded formulation of metformin (n=29) or placebo (n=29). Continuation of stable doses of MTX (25mg/week), NSAIDs, and/or corticosteroids (prednisone <10 mg/day) was permitted. Metformin drug pause on the day of MTX was given. Folic acid supplementation was given to both groups. The primary clinical endpoint was the ACR 20% (ACR20) response at 24 weeks. Secondary endpoints included reduction in PASI score, Health Assessment Questionnaire- Disability Index (HAQ-DI) and Psoriatic arthritis response criteria (PsARC) score.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 56 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Metformin: A Valid Add-On Drug in the Treatment of Psoriatic Arthritis-Randomized Controlled Trial |
Study Start Date : | September 2013 |
Actual Primary Completion Date : | March 2014 |
Actual Study Completion Date : | April 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Metformin
500 mg metformin
|
Drug: Metformin
500mg/day retarded formulation of metformin |
Placebo Comparator: Placebo
500 mg of placebo tablets
|
Drug: Placebo
500 mg/day of placebo tablets |
- ACR20 response [ Time Frame: 24 weeks ]
- PASI score [ Time Frame: 24 weeks ]
- Health Assessment Questionnaire [ Time Frame: 24 weeks ]
- Disability Index (HAQ-DI) [ Time Frame: 24 weeks ]
- Psoriatic arthritis response criteria (PsARC) score [ Time Frame: 24 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Psoriatic arthritis patients
Exclusion Criteria:
- other inflammatory conditions

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188654
Egypt | |
University of Alexandria | |
Alexandria, Egypt, 00203 |
Principal Investigator: | Anna Abou-Raya, MD | University of Alexandria |
Responsible Party: | Anna Abou-Raya, MD, University of Alexandria |
ClinicalTrials.gov Identifier: | NCT02188654 |
Other Study ID Numbers: |
alexmed12671416 |
First Posted: | July 11, 2014 Key Record Dates |
Last Update Posted: | July 11, 2014 |
Last Verified: | July 2014 |
psoriatic arthritis inflammation metabolic syndrome metformin |
Arthritis Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spondylitis Spinal Diseases |
Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases Metformin Hypoglycemic Agents Physiological Effects of Drugs |