Nordli

Researchers are evaluating whether proactive therapeutic drug monitoring (TDM) is better than standard care for maintaining steady disease control in adults with rheumatoid arthritis (RA) who are treated with a subcutaneous tumor necrosis factor inhibitor (adalimumab). This Phase 4 study aims to determine if adjusting drug doses based on regular blood tests for drug levels and anti-drug antibodies can prevent disease flare-ups more effectively than standard dosing without such monitoring. Participants will be randomly assigned to one of two groups. The TDM group will have their adalimumab doses adjusted following specific rules based on blood test results to keep drug levels within a therapeutic range. Dose intervals may be shortened, lengthened, or therapy switched depending on antibody levels and drug concentration. The standard care group will continue treatment without these blood test-based adjustments. The study lasts 18 months with visits at baseline, 4, 8, 12, and 18 months, along with digital visits at 2, 6, 10, 14, and 16 months, including blood sampling at each visit. Participants will have regular blood tests to measure drug levels and antibodies every two months. They will attend on-site and digital visits for assessments of disease control and safety. The primary outcome is sustained disease control without flare over the 18-month follow-up. Researchers will monitor adherence, safety, and treatment effectiveness throughout the study period to compare the two treatment approaches.

Researchers are evaluating if a treat-to-target approach that includes structured imaging assessments leads to better long-term outcomes in patients with psoriatic arthritis compared to a conventional treat-to-target strategy. Psoriatic arthritis is a complex disease that can be hard to assess clinically, and imaging techniques like ultrasound and magnetic resonance imaging (MRI) can reveal inflammation not detected through clinical exams. This study specifically aims to see if adding these imaging assessments improves the chances of sustained remission, defined as very low disease activity at 16, 20, and 24 months. The study randomly assigns patients into two groups for a 24-month follow-up. One group receives conventional treat-to-target care based on clinical disease activity assessments alone. The other group follows an imaging informed treat-to-target strategy that includes ultrasound assessments of joints, tendons, and entheses at every visit and MRI scans of the spine and sacroiliac joints at the start and one year. If imaging shows signs of enthesitis or axial inflammation, patients in the imaging group move directly to biological disease modifying antirheumatic drug treatment. Ongoing inflammation detected by ultrasound indicates the treatment target has not been reached. Participants will be monitored regularly with clinical and imaging assessments to track disease activity, inflammation, quality of life, and any adverse events. Outcomes include sustained remission at 16, 20, and 24 months, as well as other disease activity measures and safety. The study follows current European treatment recommendations, and all patients are treated according to a defined algorithm. The total study duration for each participant is 24 months.

Researchers are evaluating the effectiveness and safety of intraarticular corticosteroid injections and a combined occupational therapy program for people with inflammatory osteoarthritis of the thumb base joint (CMC-1 OA). This Phase 4 trial compares these treatments head-to-head against a placebo injection of saline. The study focuses on patients with painful and inflammatory CMC-1 OA confirmed by imaging and symptoms, aiming to tailor treatment based on individual patient characteristics and to explore predictors of treatment success. It also investigates the long-term safety of steroid injections and whether occupational therapy can prevent joint subluxation. Participants will receive one of three interventions: an injection of triamcinolone acetonide into the thumb joint, an injection of saline as a placebo, or a multimodal occupational therapy program that includes patient education, hand exercises, use of orthoses, and training. The injections are ultrasound-guided and dosed appropriately to maximize safety and effectiveness. The occupational therapy involves multiple components aimed at improving hand function. The study is structured in phases that include initial treatment and longer-term follow-up to assess safety and joint stability. During the study, participants will be monitored for pain during thumb joint activities at 4 and 12 weeks. Assessments include imaging by ultrasound or radiographs to confirm osteoarthritis and inflammation, pain ratings using a numeric scale, and evaluations of treatment safety and joint stability over time. Researchers will track participants’ adherence to treatments and monitor for side effects or complications. The total involvement period includes screening, treatment, and follow-up assessments to gather comprehensive data on outcomes and safety.

Researchers are studying patients with self-harm behaviors and borderline personality disorder who are receiving Dialectical Behaviour Therapy (DBT) in clinical units across Norway. The goal is to identify factors that predict how patients respond to treatment and their clinical progress, including the impact of patient characteristics like psychiatric diagnoses, previous behaviors, and treatment history. This project is a collaboration between the National Centre for Suicide Research and Prevention and clinical DBT programs, using a standardized system to collect and compare treatment data across different settings. The study includes two types of DBT treatments: one adapted for adolescents (DBT-A), which involves 20 weeks of weekly individual therapy, multifamily skills training, family therapy as needed, and telephone coaching; and the standard DBT version for adults, which consists of weekly individual therapy, weekly skills training, and telephone coaching as needed. Treatments are delivered by clinical units that use a uniform protocol for psychiatric diagnosis and clinical assessment, tailored for either children/adolescents or adults. Participants will undergo baseline assessments before treatment, multiple evaluations during therapy, at treatment end, and during follow-up. Data collection includes interviews and ratings by therapists plus self-reports by patients using tablets and a mobile app for frequent emotional and behavioral tracking. Researchers will measure outcomes such as self-harm behavior, suicidal thoughts, depressive symptoms, emotional regulation, coping skills, social and occupational functioning, and use of emergency services to better understand treatment response and clinical changes over time.

Researchers are evaluating a new psychotherapeutic approach called the Seven-Step Phenomenological Psychotherapy for Self-Disorders (SSPP-SD) in adults with schizophrenia, other non-affective psychotic disorders, or psychosis risk syndromes. Self-disorders, which affect the sense of self and reality, are central features of schizophrenia spectrum disorders and can cause significant distress, anxiety, and functional difficulties. This pilot study aims to understand how participants experience this novel treatment, including its helpfulness and impact on self-experience and relationships. The treatment consists of up to 14 individual therapy sessions over 7 to 10 weeks, focusing on exploring unusual self-experiences, understanding their meaning and behavioral effects, and providing psychoeducation. The therapy uses a dialogical method to explore self-narratives and develop new understanding. It begins with a semi-structured interview using the Examination of Anomalous Self-Experience (EASE). Two trained therapists, supervised by the model's developer, provide the treatment to six participants recruited from an outpatient psychotic disorders clinic. Participants will be interviewed after completing treatment to capture their experiences of the therapy, including positive and negative aspects. They will also complete questionnaires before and after treatment about symptoms, functioning, quality of life, and satisfaction. Therapists' adherence to the manual and their experiences with the therapy are also evaluated. The study's findings will help plan a larger clinical trial of SSPP-SD for people with psychotic disorders at Vestre Viken Hospital in Norway.

Researchers are evaluating the treatment options for displaced olecranon fractures in patients aged 75 years or older. The study compares surgical methods, specifically tension band wiring (TBW) or plate fixation (PF), against non-operative treatment. Operative treatments aim to restore the elbow's extensor mechanism but are linked to high complication and reoperation risks in the elderly. Previous trials were limited, prompting this study to better understand outcomes for these patients. Participants will be randomly assigned to receive either operative treatment using TBW or PF, determined by the treating surgeon, or active non-operative treatment. Those in the non-operative group may use a back-slab cast positioned at 60 degrees of elbow flexion for pain relief, which is removed after 7 to 14 days. Surgical procedures follow established orthopedic trauma principles and are performed by experienced surgeons or qualified consultants at participating centers. Throughout the 52-week study, researchers will assess participants using the Oxford Elbow Score to measure elbow function and outcomes. Data on complications, reoperations, and recovery progress will be collected to compare the effectiveness and safety of both treatment approaches. This study helps inform the best care practices for elderly patients with displaced olecranon fractures.