Reported trial results for Polymyalgia Rheumatica

7 trials have reported results.

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• NCT04972968 · results posted 15 October 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04972968) enrolled 181 adults in total across four groups: 50 received a placebo (a dummy injection), and 42, 45, and 44 received different doses of an investigational medicine called ABBV-154 (40 mg, 150 mg, and 340 mg, given as an injection under the skin). The trial was looking at polymyalgia rheumatica (PMR), a condition causing muscle pain and stiffness, and was mainly measuring how long it took before participants experienced a "flare" — meaning their symptoms returned and their doctor needed to increase their steroid dose. It is worth noting that relatively few participants completed the full study period: 12 in the placebo group and 7–8 in each ABBV-154 group. The reported data shows that the main outcome — time to flare — was 113 days on average for the placebo group and 225 days for the lowest dose (40 mg) group. For the two higher doses (150 mg and 340 mg), a time-to-flare figure was not reported in the submitted data, which may indicate that not enough flare events occurred in those groups to calculate a meaningful average. For the secondary outcomes, the percentage of participants who remained flare-free throughout the study was reported as 11% (placebo), 13% (40 mg), 15% (150 mg), and 24% (340 mg). The reported data also shows the total steroid dose taken over the study was 984.6 mg for the placebo group, compared with 823.4 mg, 734.3 mg, and 759.5 mg for the three ABBV-154 doses respectively. The reported change in steroid dose from the start of the study was a reduction of approximately 5.0 mg for placebo, and reductions of 6.3 mg, 7.4 mg, and 7.9 mg for the three ABBV-154 doses. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03600818 · results posted 10 June 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03600818) looked at a condition called polymyalgia rheumatica (PMR), which is an inflammatory condition causing pain and stiffness, mainly in the shoulders and hips. A total of 118 people took part — 58 received a placebo (an inactive treatment) alongside a standard 52-week course of the steroid prednisone that was gradually reduced over time, while 60 received an injection called sarilumab (200 mg every two weeks) alongside a shorter 14-week prednisone taper. The trial's main goal was to measure how many participants achieved what was called "sustained remission" by Week 52 — meaning their symptoms had resolved, their inflammation marker (a blood test called CRP) had returned to normal, they had no disease flare-ups, and they had successfully followed the steroid-reduction schedule. The reported data shows that for the main outcome, 10.3% of participants in the placebo group achieved sustained remission at Week 52, compared with 28.3% in the sarilumab group. For the secondary outcomes, the reported data shows the average total steroid dose taken over the study was approximately 2,236 mg in the placebo group and 1,040 mg in the sarilumab group. In terms of individual milestones: 22 out of 58 placebo participants and 28 out of 60 sarilumab participants reached disease remission by Week 12; 19 placebo participants and 33 sarilumab participants had no disease flare between Weeks 12 and 52; 26 placebo participants and 40 sarilumab participants maintained consistently normal CRP levels from Week 12 to Week 52; and 14 placebo participants compared with 30 sarilumab participants successfully followed the steroid-tapering schedule through to Week 52. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03923738 · results posted 22 December 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03923738) enrolled 24 participants who received a medicine called TCZ (tocilizumab) given into a vein every four weeks. The trial ran in two periods — 22 participants completed the first period and all 22 went on to complete the second period. The trial was primarily measuring how the medicine moved through the body at two different doses (7 mg/kg and 6 mg/kg), as well as recording any unwanted events (called adverse events) that participants experienced. It also measured levels of two proteins in the blood — interleukin-6 (IL-6) and soluble interleukin-6 receptor (sIL-6R) — as secondary outcomes. The reported data shows that, for the higher dose (7 mg/kg), the peak level of the medicine in the blood reached 197 micrograms per millilitre (µg/mL), while the lower dose (6 mg/kg) reached a peak of 178 µg/mL. The lowest level of medicine remaining in the blood just before the next dose (called the trough level) was reported as 37.2 µg/mL for the 7 mg/kg group and 22.7 µg/mL for the 6 mg/kg group. The total amount of medicine the body was exposed to over the four-week dosing period was reported as 2,130 for the 7 mg/kg group and 1,610 for the 6 mg/kg group (measured in day×µg/mL). Regarding adverse events, the reported data shows that 79.2% of participants in the 7 mg/kg group and 40.9% in the 6 mg/kg group experienced at least one adverse event. The secondary outcome data showed various blood protein level readings across different time points for both groups; however, the specific time points those individual measurements correspond to were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00556439 · results posted 26 February 2018

  According to the results reported on ClinicalTrials.gov, this trial looked at two related conditions that cause inflammation of blood vessels — Giant Cell Arteritis (GCA) and Takayasu Arteritis (TAK). The trial had two stages. In the first stage (up to week 12), all participants received the study drug, abatacept: 49 people with GCA and 34 people with TAK. Those who responded and achieved remission (meaning their disease became inactive) then moved into the second, randomised stage, where they were randomly assigned — without knowing which they received — to either continue with abatacept or switch to a placebo (a dummy treatment with no active ingredient). In the randomised stage, 20 GCA participants received abatacept and 21 received placebo; 11 TAK participants received abatacept and 15 received placebo. The main thing the trial was measuring was "relapse-free survival" — that is, how many participants stayed in remission without their disease coming back. The reported data shows that in the GCA group, 10 out of 20 participants on abatacept remained relapse-free, compared with 7 out of 21 on placebo. In the TAK group, 8 out of 11 participants on abatacept remained relapse-free, compared with 5 out of 15 on placebo. The reported data also shows the number who did relapse: 10 out of 20 in the abatacept GCA group and 14 out of 21 in the placebo GCA group experienced a relapse, while 3 out of 11 in the abatacept TAK group and 10 out of 15 in the placebo TAK group experienced a relapse. No other outcome measures were included in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00836810 · results posted 5 February 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 11 people in total — 5 in the timed-release prednisone tablet group and 6 in the standard prednisolone group. One person in the timed-release group did not complete the trial; all 6 in the standard group finished. The trial was measuring changes in a substance in the blood called IL-6 (a chemical the body produces during inflammation), as well as self-reported morning stiffness, pain, and opinions of how the condition was affecting participants. Blood samples were taken at multiple time points across two nights — one before treatment and one after — to track how IL-6 levels changed over the course of treatment. The reported data shows that for the main (primary) outcomes, the timed-release prednisone group had a reported reduction in peak IL-6 blood levels of 11.5 pg/ml (a unit measuring tiny concentrations in the blood), compared with 29.3 pg/ml in the standard prednisolone group. A second way of measuring IL-6 — by adding up levels across the whole night (called "area under the curve," meaning the overall amount over time) — showed a reduction of 113.5 units in the timed-release group and 97.9 units in the standard group. For the secondary outcomes, morning stiffness showed a reported percentage reduction of 75% in the timed-release group and 115% in the standard group. Pain scores (on a scale of 0–100, where higher means more pain) were reported as 26.5 mm for the timed-release group and 19.5 mm for the standard group after treatment. Participants' own ratings of how they were doing scored 17.8 mm and 26.0 mm respectively, and clinicians' ratings of disease activity were 19.0 mm and 20.3 mm. It is worth noting that this was a very small trial with only 11 participants across both groups, and the reported data does not include information about variability or statistical comparisons between groups, so these numbers should be interpreted with great caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01396317 · results posted 17 January 2018

  According to the results reported on ClinicalTrials.gov, this small trial (NCT01396317) enrolled 20 people with polymyalgia rheumatica (PMR) — a condition causing pain and stiffness, usually in the shoulders and hips. Ten participants received the drug tocilizumab alongside a tapering course of corticosteroids (steroid tablets that were gradually reduced over time), while the other ten received the corticosteroid taper on its own. The trial was measuring whether patients reached a state of "disease remission" — meaning their symptoms had settled and they were no longer taking steroids — at six months, and also tracking any unwanted side effects over a 15-month period. The reported data shows that, at six months, 9 out of 10 participants in the tocilizumab group were reported to be in remission off corticosteroids without their symptoms returning, compared with 0 out of 10 in the corticosteroid-only group. When looking at disease relapses (symptoms coming back while still on steroids) and recurrences (symptoms returning after steroids were stopped), the reported data shows 0 such events in the tocilizumab group versus 7 incidents in the control group. The reported total cumulative dose of prednisone (the steroid used) was around 1,085 milligrams in the tocilizumab group compared with approximately 2,562 milligrams in the control group. Regarding safety, the reported data shows 23 adverse events (unwanted health events that occurred during the study) were recorded among tocilizumab participants, along with 1 additional event — though the data as submitted does not provide further breakdown of what those events were. It is worth noting this was a very small trial of only 20 people, and the numbers reported here reflect that limited scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01364389 · results posted 4 March 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 16 people in total across three groups: 5 received ACZ885 (canakinumab), 6 received AIN457 (secukinumab), and 5 received prednisone (a steroid). The trial was measuring how well a single dose of each treatment reduced disease activity in people with polymyalgia rheumatica (PMR), a condition causing pain and stiffness, particularly in the shoulders and hips. Disease activity was tracked using a combined score called the PMR Activity Score, which drew on blood test results, morning stiffness, ability to lift the arms, pain levels, and a doctor's overall assessment. The study was terminated early because the data did not show that the two biological treatments reduced disease activity to the same degree as the steroid treatment within the first two weeks. The reported data shows that, by day 15, the prednisone group had an average reduction in their PMR Activity Score of 91.9%, compared with 64.5% for the ACZ885 group and 51.7% for the AIN457 group. When looking at "partial response" — defined as at least a 50% improvement in how participants rated their own condition plus morning stiffness of less than 60 minutes — 75% of the prednisone group met this measure, compared with 20% in the ACZ885 group and 16.7% in the AIN457 group. For "complete response" — a stricter set of targets including blood marker levels — 25% of the prednisone group met the criteria, while 0% in either of the other two groups did. Only one participant (in the AIN457 group) experienced a disease flare during the study, which occurred on day 44. The reported data also shows figures for average steroid doses used over six months: 428.9 doses for the prednisone group, 276.8 for the ACZ885 group, and 256.7 for the AIN457 group, though it is worth noting the trial was terminated early and the numbers of participants in each group were very small, which limits how much can be drawn from these figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.